Pfizer
Skin & localized to injection site symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | tingling |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2020-12-31 | injection site redness, injection site warmth, injection site swelling, injection site pain |
Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 day...
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Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 days after injection. I had none of the above directly after or in the 48 hours after the injection. There was absolutely no tenderness to injection site.
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| 40 | 2020-12-31 | injection site pain |
Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with a...
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Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone
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| 40 | 2021-01-01 | rash |
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad...
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Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
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| 40 | 2021-01-01 | itchy skin | itching sensation. No rash. No shortness of breath. No anaphylaxis. |
| 40 | 2021-01-02 | injection site numbness, injection site pain, injection site tingling |
Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Ini...
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Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days
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| 40 | 2021-01-03 | vaccination site redness, vaccination site swelling | Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea. |
| 40 | 2021-01-03 | hives, rash | Hives/rash on both arms and chest |
| 40 | 2021-01-03 | injection site mass |
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; ...
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I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
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| 40 | 2021-01-03 | injection site pain, injection site mass |
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted...
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Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
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| 40 | 2021-01-03 | tingling |
Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal a...
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Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal area of scalp within 30 min of vaccine that persisted x 90 min. Also reported transient "numbness" of R anterior thigh that resolved spontaneously after 30 min. No pruritic, urticaria, rash. No mucus membrane symptoms - no conjunctivitis, rhinitis or oral/perioral symptoms. No mucosal swelling or sense of swelling. No respiratory symptoms. No presyncopal symptoms. Vitals: BP 134/87, Pulse 103, sats 100%.
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| 40 | 2021-01-03 | hives | local- soreness systemic/local-urticaria |
| 40 | 2021-01-04 | tingling |
About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek...
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About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.
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| 40 | 2021-01-04 | swelling, rash |
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4...
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Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-04 | itchy skin, hives |
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join...
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Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
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| 40 | 2021-01-04 | tingling |
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h...
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Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 40 | 2021-01-04 | hardening |
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s...
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One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
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| 40 | 2021-01-04 | rash |
Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with...
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Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products. No follow up attempts are needed. No further information is expected.
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| 40 | 2021-01-04 | tingling |
numbness and tingling in all four extremities; numbness and tingling in all four extremities; interm...
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numbness and tingling in all four extremities; numbness and tingling in all four extremities; intermittent weakness in my hands, arms and legs; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0140), via an unspecified route of administration on the left arm on 18Dec2020 12:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 13:30, the patient was experiencing numbness and tingling in all four extremities after the first dose of the vaccine. The patient also experienced intermittent weakness in hands, arms and legs. It was also mentioned that the patient had numbness and tingling in all four extremities for the past 10 days. The patient did not receive any treatment for the events. Outcome of the events were unknown.
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| 40 | 2021-01-05 | tingling |
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling...
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After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
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| 40 | 2021-01-05 | vaccination site pain |
Burning when the medication was injected; Injection was given under the shoulder bone instead of the...
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Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.
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| 40 | 2021-01-05 | injection site pain |
I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience...
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I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.
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| 40 | 2021-01-05 | tingling | Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities |
| 40 | 2021-01-05 | redness, rash, hives |
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R...
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Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
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| 40 | 2021-01-05 | itchy skin, rash |
Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the ...
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Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the evening on 12/25/2020. Took Benadryl at onset. Did not seek medical attention. Reported incident on 01/06/2021. Rash almost gone, remaining only on left hand and very faded.
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| 40 | 2021-01-05 | vaccination site itchiness, vaccination site swelling, vaccination site warmth, vaccination site redness |
Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours sinc...
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Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; This is a spontaneous report from a non-contactable nurse who reported for herself. A 40-year-old female patient received first single dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Lot number: EL0140) intramuscularly at right arm at 10:00 AM on 29Dec2020 for Covid-19 immunization. The patient received the vaccine in hospital. The patient had a history of hypothyroidism and had known allergies to sulfa. Concomitant medications in two weeks included Levothyroxine, amlodipine, losartan, drospirenone, ethinylestradiol betadex clathrate (YAZ), tizanadine, montelukast sodium (SINGULAIR), terbinafine (LAMISIL), cetirizine hydrochloride (Zyrtec). At 12:00PM on 29Dec2020, the patient developed red, raised, itchy bump at the insertion site that was warm to the touch. No treatment was received. The events had not resolved at the time of reporting. The reporter considered the events were non-serious. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-05 | tingling |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-05 | tingling | Tingling in fingers Fingers contracting without pain, only tingling |
| 40 | 2021-01-05 | injection site reaction, injection site pain |
Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion...
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Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.
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| 40 | 2021-01-05 | injection site pain |
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte...
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Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
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| 40 | 2021-01-05 | itchy skin, injection site warmth |
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea...
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Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
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| 40 | 2021-01-05 | hives |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-05 | vaccination site swelling, vaccination site redness, vaccination site itchiness, injection site pain |
a red area at the injection site /growing red spot at injection site; raised area at the injection s...
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a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.
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| 40 | 2021-01-05 | vaccination site pain, vaccination site redness |
hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore a...
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hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020 at 18:00 as single dose for COVID-19 immunization. Medical history included herpes simplex 1 (HSV1) from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious. Therapeutic measures were taken as a result of the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.
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| 40 | 2021-01-06 | tingling, shingles |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-06 | itchy skin, swelling, hives | Angioedema & UrticariaPruritus |
| 40 | 2021-01-06 | injection site pain |
Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had co...
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Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.
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| 40 | 2021-01-06 | redness, itchy skin |
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j...
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Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
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| 40 | 2021-01-06 | hives, itchy skin |
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful...
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On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
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| 40 | 2021-01-06 | itchy skin, rash papular |
Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 ...
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Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 mg Benadryl PO. Patient waited additional 20 minutes. Rash persists. Patient described sensation of slight itching on legs. Denies and shortness of breath or itching of throat. Patient advised not to drive if she felt any sleepiness. She verbalized understanding.
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| 40 | 2021-01-06 | injection site swelling, tingling |
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i...
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Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
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| 40 | 2021-01-06 | rash | rash on arms and torso; shortness of breath, and body aches |
| 40 | 2021-01-07 | rash |
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re...
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Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
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| 40 | 2021-01-07 | rash, redness |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | tingling | Dizziness Tingling Left arm to finger tips. |
| 40 | 2021-01-07 | itchy skin |
Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom ...
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Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.
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| 40 | 2021-01-07 | sensitive skin |
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s...
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Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
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| 40 | 2021-01-07 | itchy rash, hives |
Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, c...
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Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse. A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment with diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
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| 40 | 2021-01-07 | hives, rash, injection site pruritus |
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later wit...
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Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
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| 40 | 2021-01-07 | itchy skin |
Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with r...
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Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.
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| 40 | 2021-01-07 | tingling |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | rash papular, itchy skin |
Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This i...
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Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration at left arm on 05Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products (unspecified allergies). The patient's concomitant medications were not reported. The patient experienced red bumps and itching to arms, legs and belly at 12:30 on 05Jan2021. The patient received the Benadryl as treatment. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-07 | tingling, injection site pain |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | injection site bruising, injection site warmth |
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour...
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low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
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| 40 | 2021-01-08 | sensitive skin |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | redness, rash macular, hives |
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE...
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11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
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| 40 | 2021-01-08 | injection site pain |
Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Bod...
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Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)
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| 40 | 2021-01-08 | rash | I had a rash on the back of my leg and significant pain around the rash. |
| 40 | 2021-01-08 | injection site pruritus, injection site redness, injection site hardening, injection site rash, injection site warmth |
Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given...
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Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given. Its starting to get itchy as well.
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| 40 | 2021-01-09 | pain of skin |
Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fa...
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Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.
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| 40 | 2021-01-09 | injection site pain, injection site redness, redness, itchy skin |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | rash, itchy skin |
Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical...
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Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical history, the patient was required to stay for observation for 30 minutes. Within the first 15 minutes, the patient began to experiencing itching. Initially, there was concern that she was reacting to the bandaid (history of latex allergy). The bandaid was removed and staff confirmed the bandaid was LATEX FREE. Per protocol, the patient was administered diphenhydramine 25 mg po x 1 dose. After 15 minutes, the patient's itching continued and she started to develop a skin rash on her chest. Diphenhydramine 25 mg po x 1 dose was repeated and the decision was made to take the patient to the Emergency Department in a wheelchair. Documentation from the Emergency Department Provider: 40 y/o F who comes in from the covid vaccine clinic for a possible allergic reaction. Initially thought to be to latex but then we found out she was not given a bandaid with latex so we assume it is the vaccine. pt had a rash and scratchy throat and initialy felt improved with the benadryl, pepcid and steroids but after about 2 hours had recurrence of her sx. She was then given IM epi. She has now been observed for four more hours and is still feeling well. Will d/c to home with steroids and an epi pen and epi traning. Given return precautions and f/uw ith PCP. .
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| 40 | 2021-01-10 | redness, itchy skin |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | injection site pruritus, injection site redness |
2 days after receiving the 2nd dose Of vaccine, redness, itchiness, and tiny blisters were noted ab...
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2 days after receiving the 2nd dose Of vaccine, redness, itchiness, and tiny blisters were noted about 1inch around the injection site.
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| 40 | 2021-01-10 | itchy skin, vaccination site pain |
24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous rep...
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24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.
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| 40 | 2021-01-10 | injection site warmth, injection site redness, injection site pruritus, injection site rash, injection site swelling |
About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hour...
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About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.
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| 40 | 2021-01-10 | tingling, skin burning sensation |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | hives, redness | I had large red and hot welt. I had lip node enlargement. It lasted for a week. |
| 40 | 2021-01-10 | vaccination site pain |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | injection site pain, hardening |
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ...
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Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
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| 40 | 2021-01-10 | injection site hardening, injection site warmth, injection site redness |
The person administering the vaccine did not go deep enough into the muscle and the vaccine accumula...
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The person administering the vaccine did not go deep enough into the muscle and the vaccine accumulated in the subcutaneous fat layer. I had a hard, red, hot spot under the skin that night and continued to spread out very slowly over the next day being hot to touch and very red. I massaged the area with my hand for the next two days and the hard spot where the vaccine was got a little softer but is still there. I haven't had any other reactions except the redness and hot to touch. I'm concerned that since the vaccine was not administered correctly that I will not get the full immunity expected by the second dose. I do have pictures I took of my arm if needed.
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| 40 | 2021-01-10 | redness |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | injection site pain |
believed it was injected incorrectly because she didn't have pain in her deltoid but she did have al...
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believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work. She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | itchy skin | itchy, clammy, sweaty |
| 40 | 2021-01-10 | tingling |
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af...
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shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
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| 40 | 2021-01-11 | redness, cellulitis, hives, bruising |
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K...
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Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
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| 40 | 2021-01-11 | skin infection at injection site, injection site bruising, redness |
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo...
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Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
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| 40 | 2021-01-11 | injection site pain, injection site warmth, injection site redness |
Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, wa...
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Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.
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| 40 | 2021-01-11 | injection site warmth, injection site inflammation, injection site hardening |
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia...
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Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
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| 40 | 2021-01-11 | hardening |
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec...
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Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
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| 40 | 2021-01-11 | itchy skin, hives |
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in num...
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Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
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| 40 | 2021-01-11 | itchy skin, rash |
Pt developed itching and a rash on her arm approximately 2 hours post vaccine. colleague self medic...
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Pt developed itching and a rash on her arm approximately 2 hours post vaccine. colleague self medicated with Benadryl 7 hours post vaccine. symptoms resolved and colleague reported to work the following day without issue
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| 40 | 2021-01-11 | rash |
Rash appear on my arm that Sunday. The rash was all over my body. I was on heavy Benadryl for abo...
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Rash appear on my arm that Sunday. The rash was all over my body. I was on heavy Benadryl for about 1 week.
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| 40 | 2021-01-11 | injection site pain |
Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it...
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Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it was subcutaneous. My dose was a waste and I may not have immunity due to operator error.
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| 40 | 2021-01-11 | injection site swelling |
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours...
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swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
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| 40 | 2021-01-12 | tingling |
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va...
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?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
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| 40 | 2021-01-12 | redness, itchy skin, injection site swelling, injection site redness, injection site rash, rash macular, rash |
ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE. BY THE TIME I MADE ...
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ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE. BY THE TIME I MADE IT OUT TO MY FIRE ENGINE I WAS RED AND BLOTCHY ON MY CHEST AND BACK THAT STARTED TO GO UP MY NECK. ONE OF MY FIREFIGHTERS GAVE ME BENADRYL IM IN THE RIGHT ARM. THE ITCHING STAYED THE SAME FOR ANOTHER 10 MINUTES UNTIL IT STARTED TO GET WORSE AND MOVE DOWN MY SIDE, STOMACH, LEGS AND ARMS. I THEN STARTED TO DEVELOP BUMPS AND REDNESS TO MY NECK AND BEHIND BOTH MY EARS AND BOTH MY FOREARMS. IN THE ARM WHERE I RECEIVED THE VACCINE IT TURNED RED WITH SOME SWELLING AND BUMPS. MY PARAMEDIC THEN GAVE A DOSE OF EPI 1:1,000 IM ON THE LEFT ARM. ABOUT 1 HOUR LATER THE MAJORITY OF THE BUMPS AND ITCHING WENT AWAY. ABOUT 10 HOURS LATER THE REDNESS AND SWELLING ON THE LEFT ARM WHERE I RECEIVED THE VACCINE WENT AWAY.
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| 40 | 2021-01-12 | injection site hardening, injection site redness |
Employee had first Pfizer COVID-19 vaccine on 12/16/20 at hospital. She developed an erythematous i...
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Employee had first Pfizer COVID-19 vaccine on 12/16/20 at hospital. She developed an erythematous indurated firm wheal at injection site post-vaccination that lasted for 2 weeks. Evaluated in EH clinic on 12/28/20 and referred to PCP for treatment. Prescribed antibiotics and resolved without complications.
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| 40 | 2021-01-12 | tingling |
I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was init...
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I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse
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| 40 | 2021-01-12 | rash, itchy skin |
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf...
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I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
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| 40 | 2021-01-12 | skin burning sensation |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | tingling |
Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbnes...
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Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm, on 06Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included chronic migraine and allergies to medications, food, or other products including penicillin. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) for birth control. The patient previously took piroxicam and experienced allergy. The patient was not pregnant. The patient was not diagnosed with covid-19 prior to vaccination nor was she tested for Covid-19 since vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5 on 07Jan2021, 10:00 AM, with outcome of not recovered. The events were reported as non-serious with no treatment received.
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| 40 | 2021-01-12 | vaccination site pain |
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we...
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heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
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| 40 | 2021-01-12 | rash, itchy skin, bruising |
itching (benadryl did not relive) strange dark rash/bruising or lesions on left side of body- includ...
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itching (benadryl did not relive) strange dark rash/bruising or lesions on left side of body- including lower extremity. Painful.
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| 40 | 2021-01-12 | vaccination site pain |
soreness at the injection site; This is a spontaneous report from a non-contactable other healthcare...
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soreness at the injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), via an unspecified route of administration at the left arm on 06Jan2021 17:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT C), ergocalciferol (VIT D), glucosamine and curcuma longa (TURMERIC). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced soreness at the injection site on an unspecified date. The patient assessed the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-13 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in he...
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After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in her feet and traveled up her legs. Patient refused PO benadryl but took Cetirizine 10 mg PO X 1. Patient was instructed to wait for 30 minutes of observation. At that time, the patient reported that the tingling sensation remained. The patient was offered to be taken to the emergency department, but decided to leave against medical advice.
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| 40 | 2021-01-13 | vaccination site pain |
Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm sore...
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Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 40 | 2021-01-13 | injection site rash, injection site pruritus, injection site swelling, injection site pain | FIVE DAYS OF SINTOMES,PAIN INJECTIN SITE, SWELLING INJECTION SITE, RASH AND INCHING. |
| 40 | 2021-01-13 | injection site warmth, injection site redness, injection site swelling |
Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen...
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Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.
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| 40 | 2021-01-13 | itchy skin, rash papular, rash, hives |
Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would po...
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Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.
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| 40 | 2021-01-13 | tingling |
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle...
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In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
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| 40 | 2021-01-13 | injection site pain | Low grade fever (99.8-100.2), headache, fatigue, and soreness at injection site |
| 40 | 2021-01-13 | tingling |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-14 | injection site redness, injection site swelling, injection site pruritus |
"after my 2nd shot i got a swollen area, with some redness which according the email was normal but ...
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"after my 2nd shot i got a swollen area, with some redness which according the email was normal but what concerned me was alot of itching to the site which is still there along with the redness and swelling."
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| 40 | 2021-01-14 | tingling |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | vaccination site pain |
Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-co...
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Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-14 | injection site pain |
HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums ...
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HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.
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| 40 | 2021-01-14 | injection site pain, injection site redness, bruising |
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine....
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Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
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| 40 | 2021-01-14 | tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minu...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minutes after injection. Resolved approximately 2-3 hours later.
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| 40 | 2021-01-14 | rash, itchy skin | Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching |
| 40 | 2021-01-15 | bruising |
My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless ...
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My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.
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| 40 | 2021-01-16 | injection site pain | Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea. |
| 40 | 2021-01-16 | injection site bruising |
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in...
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Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
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| 40 | 2021-01-17 | tingling | - My fingers are tingling - I can't grab anything or type very well |
| 40 | 2021-01-19 | rash |
1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen p...
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1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.
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| 40 | 2021-01-19 | tingling |
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21...
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Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
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| 40 | 2021-01-19 | vaccination site pain |
Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08J...
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Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-19 | injection site redness | Ongoing treatment for vertigo |
| 40 | 2021-01-19 | rash | Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills |
| 40 | 2021-01-19 | tingling | Upper back pain, shoulder and neck pain, numbness in arms, tingling- ongoing for one week |
| 40 | 2021-01-20 | injection site pain, injection site redness |
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien...
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temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-21 | redness, rash |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-21 | injection site pain |
No symptoms or reactions immediately. Injection site was very sore the following day. Followed by b...
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No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.
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| 40 | 2021-01-21 | tingling, itchy skin |
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr...
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Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
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| 40 | 2021-01-24 | hives, itchy skin |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | injection site warmth, injection site redness |
Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased o...
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Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased on Sunday -- injection was Friday.
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| 40 | 2021-01-24 | injection site pain, injection site swelling, injection site redness |
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injecte...
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Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
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| 40 | 2021-01-24 | vaccination site swelling |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-25 | tingling |
5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified ...
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5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified the nurse. She left to get the head nurse. Within 2 minutes my arm was numb below my elbow. This lasted 10 minutes. The feeling came back. Later that day my left upper back was sore. Since then (2 weeks) I still have numbness and tingling in my elbow and left pinky finger with occasional pain in my left upper back.
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| 40 | 2021-01-25 | itchy skin | Itching to face and chest around 3 hours after administration. Facial swelling noted overnight. |
| 40 | 2021-01-25 | injection site hives, itchy skin, rash macular, hives |
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte...
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On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
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| 40 | 2021-01-25 | rash |
Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneou...
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Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-01-25 | tingling |
a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super di...
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a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
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| 40 | 2021-01-25 | injection site pain, skin discolouration |
pain in injection site. I noticed today that my skin had peeled away at the injection site after my...
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pain in injection site. I noticed today that my skin had peeled away at the injection site after my son pointed it out. There is a large square and of skin peeled away. The skin is also discolored.
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| 40 | 2021-01-25 | redness | pain, redness, and warm to touch, progressively has gotten worse |
| 40 | 2021-01-26 | injection site redness, injection site warmth, injection site pain |
36 hours after the injection I developed large red, warm and painful area at the injection site. 24 ...
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36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit
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| 40 | 2021-01-26 | itchy skin |
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap...
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About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
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| 40 | 2021-01-26 | injection site pain | Fatigue Pain at injection site |
| 40 | 2021-01-26 | hives | Patient developed urticaria migratory about one week after shot |
| 40 | 2021-01-26 | injection site pain |
woke up during the night after her second dose (dose given on Friday) with joint pain (around midnig...
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woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.
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| 40 | 2021-01-28 | rash |
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira...
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Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
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| 40 | 2021-01-28 | tingling |
Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a cont...
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Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
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| 40 | 2021-01-28 | injection site pain |
I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injectio...
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I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
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| 40 | 2021-01-28 | shingles |
Shingles involving R. flank, with first lesion presenting 15JAN. Treated with valacyclovir, amitript...
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Shingles involving R. flank, with first lesion presenting 15JAN. Treated with valacyclovir, amitriptyline, prednisone. Treatment still ongoing on 29JAN
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| 40 | 2021-01-28 | injection site pain |
The muscle at the injection site was sore. It progressively got worse over about 12 hours and the ne...
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The muscle at the injection site was sore. It progressively got worse over about 12 hours and the next morning I could barely lift it equal to my shoulder. The soreness was manageable and it was gone by the next morning.
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| 40 | 2021-01-28 | itchy skin |
approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also ha...
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approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home
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| 40 | 2021-01-28 | rash, itchy skin |
patient developed itching and rash on chest and neck with some throat tightness. RRT called and she...
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patient developed itching and rash on chest and neck with some throat tightness. RRT called and she was transferred to the ER
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| 40 | 2021-01-31 | hives |
Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient de...
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Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.
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| 40 | 2021-02-02 | tingling, rash macular |
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o...
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tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-03 | injection site tingling, tingling, injection site pain, injection site numbness |
12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1...
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12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.
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| 40 | 2021-02-04 | shingles |
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey...
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Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-07 | tingling |
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ...
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inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 40 | 2021-02-08 | tingling, injection site numbness |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-10 | injection site pain |
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ...
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Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
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| 40 | 2021-02-11 | rash |
About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red ra...
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About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.
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| 40 | 2021-02-18 | hives, itchy skin |
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar...
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Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
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| 40 | 2021-02-21 | tingling |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | vaccination site redness, vaccination site swelling, vaccination site warmth |
Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to...
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Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.
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| 40 | 2021-02-21 | tingling |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-22 | injection site swelling, injection site pain |
Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I ha...
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Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.
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| 40 | 2021-02-22 | injection site redness, injection site rash |
Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a we...
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Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.
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| 40 | 2021-02-22 | injection site discomfort |
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph...
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Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
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| 40 | 2021-02-22 | injection site redness, injection site pain, injection site swelling | generalized muscle ache fatigue injection site swelling, errythema and pain Headache |
| 40 | 2021-02-23 | injection site discomfort |
Following the injection, after approximately four hours later I began to feel some slight disorienta...
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Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
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| 40 | 2021-02-23 | vaccination site pain |
Pain at the site of injection; This is a spontaneous report from a contactable other healthcare prof...
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Pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 26Jan2021 12:45 PM at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included azelastine hydrochloride/fluticasone propionate (DYMISTA) and cetirizine hydrochloride. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 26Jan2021 16:00, the patient experienced pain at the site of injection. The event was considered as non-serious by the other healthcare professional. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.
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| 40 | 2021-02-24 | hives |
light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other H...
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light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-02-25 | tingling |
Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right e...
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Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.
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| 40 | 2021-02-28 | vaccination site pain |
Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient)...
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Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-02-28 | redness, skin discolouration |
Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and r...
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Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
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| 40 | 2021-02-28 | rash |
rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displ...
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rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
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| 40 | 2021-03-02 | tingling |
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef...
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Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
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| 40 | 2021-03-07 | tingling |
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre...
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Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
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| 40 | 2021-03-14 | vaccination site itchiness, vaccination site redness, vaccination site warmth, vaccination site swelling |
injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and ...
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injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; knot at her injection site; This is a spontaneous report from a non-contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9262, first dose (at the age of 40 years), intramuscular on 28Jan2021 at single dose for covid-19 immunisation. COVID-19 vaccine was administered at hospital. The patient medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 29Jan2021 the patient experienced injection site that was raised, red, itchy and warm. One week later she still had a knot at her injection site but it was getting smaller daily. It was unknown if treatment was received for the events. The patient contacted per PCP and it was explained that it was secondary to the vaccine administration. It was recommended to receive the 2nd dose of the vaccine in the opposite arm. The events were non serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-04-08 | redness, hives |
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio...
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Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
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| 41 | 2020-12-31 | itchy skin | Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days |
| 41 | 2021-01-02 | injection site pain | Injection Site pain, Tiredness, And Headache using Tylenol. |
| 41 | 2021-01-03 | injection site pain, injection site swelling |
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ...
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12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
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| 41 | 2021-01-03 | itchy skin, injection site pain |
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ...
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Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
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| 41 | 2021-01-03 | rash |
The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on ...
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The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.
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| 41 | 2021-01-04 | rash |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual ...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.
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| 41 | 2021-01-04 | redness, itchy skin |
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ...
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20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
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| 41 | 2021-01-04 | injection site warmth, injection site bruising, injection site pain, injection site swelling, injection site redness |
41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her lef...
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41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her left upper arm. No other vaccines were received that day. She reports a sensation of warmth and tenderness locally right after vaccination. On the evening of vaccination, she noted a small area of redness and swelling at the vaccination site. She denied anything out of the ordinary with regard to vaccine administration, except the vaccine might have been given "a little lower" than usual. She did not experience any respiratory, CV, dermatologic, or gastrointestinal signs/symptoms during observation post-vaccination or during the next several days. Post-vaccination day (PVD) one, patient noted some tenderness, warmth, redness, and some bruising surrounding the vaccination site. (SEE PVD 1 Photo); local reaction gradually resolved (SEE PVD 7 Photo) and currently, all that remains is a big bruise. On the evening of 26 Dec, patient reported having some "congestion" and took some Nyquil. She reports a good night's sleep, but upon awakening, she noted mild shortness of breath and she "couldn't open" her eyes due to swelling. She also noted her bottom lip and tongue were swollen and she experienced a tight feeling in her throat and chest. She also reports mild swelling of her hands. She denies hives/urticaria, wheezing, stridor, dysphagia, loss of consciousness, or gastrointestinal-related symptoms. Patient self-treated with oral Benadryl, Pepcid, and Zyrtec, as well as using her Albuterol inhaler. After 2 hours, her symptoms had not improved, so her spouse took her to the Emergency Room. In the ER, she was placed on a cardiac monitor, and shortly after arrival, she received IM Epinephrine (x2), followed by IV Solumedrol. She was observed for 8-10 hours and discharged home with a 5-day course of oral steroids. She was diagnosed with "anaphylaxis" and instructed to follow-up with her Primary Care Provider. Since discharge, she has continued to note some facial swelling, and on 29 Dec, she was having problems breathing for which she used her inhalers, and symptoms resolved. On the day of vaccine receipt, patient reports feeling well prior to vaccination. She denies previous vaccine reactions. She denies any exposures that might have been potential triggers to her reaction on 27 Dec – "the only thing different was the vaccine"
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| 41 | 2021-01-04 | shingles |
Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir ...
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Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir prescriptions. Rash sites dried on 12/28/20.
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| 41 | 2021-01-04 | vaccination site pain |
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na...
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Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-04 | rash, tingling |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | itchy skin, vaccination site itchiness |
Itching that began localized to the injection site then spread all over the body. Feels like a burni...
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Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
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| 41 | 2021-01-04 | itchy skin, injection site hives | PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site |
| 41 | 2021-01-05 | rash | Broke out in red rash on neck, chest and arms. Lips itchy and tinging. |
| 41 | 2021-01-05 | hives, itchy skin | Hives and itching 1 hour after receiving vaccine |
| 41 | 2021-01-05 | hardening, redness |
I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area o...
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I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area on the skin became bright pink, medium hard to the touch and very warm compared to the skin around it. The area got larger and continued to spread over about two more days. Today is 1/6/21 and the skin is back to normal. I did not get a fever, chills, or any other symptom of note.
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| 41 | 2021-01-05 | tingling |
Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minute...
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Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minutes, tingling & facial muscle tightness around mouth. Twitching & facial mouth muscle tightness for about 4 days, diminishing each day. Vaccine was given Wed evening...finally Sun was little to none symptoms.
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| 41 | 2021-01-05 | injection site pain | Injection site pain 1.5 days, extreme fatigue days 2&3 |
| 41 | 2021-01-05 | shingles | Shingles-diagnosed at Urgent Care |
| 41 | 2021-01-05 | vaccination site swelling, itchy skin, hives, vaccination site redness, vaccination site itchiness |
hives; intense itching; headache; injection site is red and raised and itches intensely.; injection ...
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hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 41 | 2021-01-05 | vaccination site redness, vaccination site warmth, vaccination site itchiness |
vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated...
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vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.
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| 41 | 2021-01-06 | injection site swelling, injection site pain, injection site redness, hives, injection site hives |
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site...
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24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
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| 41 | 2021-01-06 | redness, itchy skin |
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra...
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Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
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| 41 | 2021-01-06 | injection site pain |
Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vo...
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Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain
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| 41 | 2021-01-06 | hives | Hives, fatigue, and fever |
| 41 | 2021-01-06 | hives |
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i...
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Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
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| 41 | 2021-01-06 | rash, itchy skin |
STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This ...
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STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.
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| 41 | 2021-01-06 | hives | after receiving vaccine patient has hives on arm & body aches |
| 41 | 2021-01-06 | injection site pain |
fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - on...
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fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side
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| 41 | 2021-01-06 | injection site pain, hives, injection site hives, injection site swelling, injection site redness |
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and...
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site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
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| 41 | 2021-01-06 | tingling |
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ...
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tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
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| 41 | 2021-01-06 | injection site pain |
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F...
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woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
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| 41 | 2021-01-07 | injection site redness |
0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left ...
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0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left deltoid injection site up to her neck. Pt states that she took Benadryl at 1230 and this rash and redness is now resolved.
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| 41 | 2021-01-07 | vaccination site pain |
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache...
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Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-07 | itchy skin |
Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported ...
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Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation
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| 41 | 2021-01-07 | rash |
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur...
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Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
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| 41 | 2021-01-07 | hives | Hives, |
| 41 | 2021-01-07 | skin burning sensation, rash papular |
I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One o...
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I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One on forearm, one near antecubital, and one at inner upper arm. The bumps did not itch or have any drainage. The area increased in size, remained red, and had a central clearing, as if the skin came off the surface. The skin is now dry and cracked. I applied hydrocortisone 1% OTC on Day 7 and it caused a burning sensation to the area. The lesions are still, red, dry, no scabbing noted.
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| 41 | 2021-01-07 | injection site pain |
Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy ...
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Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.
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| 41 | 2021-01-07 | itchy skin, hives |
PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathin...
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PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathing involvement. Pt given 25mg Benadryl, symptoms began to resolve after 30-40 min.
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| 41 | 2021-01-07 | injection site pain, injection site mass |
Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? kno...
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Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-07 | vaccination site pain |
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest...
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chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
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| 41 | 2021-01-07 | vaccination site pain, tingling |
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on da...
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on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 41 | 2021-01-07 | rash |
sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a sp...
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sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.
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| 41 | 2021-01-07 | itchy skin, injection site swelling |
site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Bena...
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site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Benadryl x 2 doses with positive results
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| 41 | 2021-01-08 | swelling | Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins. |
| 41 | 2021-01-08 | itchy skin |
Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay ...
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Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released
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| 41 | 2021-01-08 | hives | Hives all over body |
| 41 | 2021-01-08 | itchy skin | Itching palms ears head and eyes itching then escalated to itching all over and swelling |
| 41 | 2021-01-08 | itchy rash, hives, rash, itchy skin |
Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after re...
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Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
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| 41 | 2021-01-08 | tingling |
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci...
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Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
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| 41 | 2021-01-08 | rash macular, rash |
c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No ...
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c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.
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| 41 | 2021-01-09 | redness, itchy skin |
COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, leg...
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COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.
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| 41 | 2021-01-10 | hives, rash, itchy skin |
41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash ...
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41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash was gradual beginning 2 days ago with progression since that time. The rash began on the abdomen 2 days ago and 1 day after her second immunization with Pfizer COVID-19 vaccine. The rash over the next 24 to 48 hours spread to the back, the chest, the arms, and inguinal folds, and popliteal areas. This morning she woke up with itching and hives on her scalp. She has used Benadryl with some relief. Patient denies shortness of breath, chest pain, nausea, or vomiting. Â There is no lip swelling or itching, tongue swelling or itching, sense of throat closing, or shortness of breath. There is been no nausea vomiting, no palpitations. Â She has no hx of similar previous allergic reactions. She denies exposure to new medications, shampoos, detergents, soaps, lotions, sprays or allergens.
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| 41 | 2021-01-10 | itchy skin |
Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and chee...
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Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.
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| 41 | 2021-01-10 | injection site redness | Arm Soreness, redness around injection site |
| 41 | 2021-01-10 | shingles, skin burning sensation, blister, rash |
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a...
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I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
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| 41 | 2021-01-10 | injection site pain | Mild soreness around injection site. Did not affect my daily activities. |
| 41 | 2021-01-10 | itchy skin, rash |
Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She to...
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Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She took Benadryl for two days, and it was gone. She had no other symptoms.
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| 41 | 2021-01-10 | injection site pain |
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-...
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Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
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| 41 | 2021-01-10 | injection site pain | Severe headache with photosensitivity, soreness at injection site, malaise |
| 41 | 2021-01-10 | tingling |
Staff of facility experiences light headiness and extreme dizziness. Patient explained that her leg...
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Staff of facility experiences light headiness and extreme dizziness. Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
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| 41 | 2021-01-10 | itchy skin, hives | itchy and generalized hives |
| 41 | 2021-01-10 | itchy skin |
palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to thro...
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palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing
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| 41 | 2021-01-11 | vaccination site pain |
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla...
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Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
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| 41 | 2021-01-11 | tingling | FLUSHING, LIGHT HEADED, AND TINGLING |
| 41 | 2021-01-11 | tingling |
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h...
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Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
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| 41 | 2021-01-11 | tingling |
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ...
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I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-11 | rash, rash macular |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | injection site pain, tingling |
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu...
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Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
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| 41 | 2021-01-11 | rash | worsening of the rash developed tender/swollen supraclavicular lymph nodes |
| 41 | 2021-01-12 | cellulitis, shingles, injection site pain |
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ...
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24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
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| 41 | 2021-01-12 | hives |
Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Bena...
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Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.
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| 41 | 2021-01-12 | injection site pain | Injection site pain, fatigue. Resolved. |
| 41 | 2021-01-12 | injection site rash, rash, itchy skin |
Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of r...
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Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of receiving the vaccine from the left elbow area (where the vaccine was administered) and gradually spread to other body parts over the next couple of hours. Has not resolved with over the counter oral anti-histamine and topical over the counter steroid cream as of 1/13/21.
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| 41 | 2021-01-12 | hives, rash |
Started having itching after vaccine. Taken to ER. Broke out in full hives. Was given IV Benadry...
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Started having itching after vaccine. Taken to ER. Broke out in full hives. Was given IV Benadryl and steroids.
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| 41 | 2021-01-12 | skin burning sensation |
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ...
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The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
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| 41 | 2021-01-12 | injection site bruising | bruising at injection site |
| 41 | 2021-01-12 | rash | fever loss of appetite headache/migraine body aches muscle cramps, rash |
| 41 | 2021-01-12 | injection site redness, injection site pruritus, injection site warmth | injection site red, hot to touch and itchy since 1/12/21 |
| 41 | 2021-01-12 | itchy skin |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
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| 41 | 2021-01-13 | injection site redness |
01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at inje...
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01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.
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| 41 | 2021-01-13 | tingling |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | tingling |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | injection site pain |
Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/l...
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Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
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| 41 | 2021-01-13 | tingling |
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324...
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Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
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| 41 | 2021-01-13 | tingling |
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I...
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Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
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| 41 | 2021-01-13 | sensitive skin |
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu...
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Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
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| 41 | 2021-01-13 | injection site redness, rash, injection site pruritus |
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other th...
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild; symptoms lasted 0 days
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| 41 | 2021-01-13 | tingling |
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn...
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Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
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| 41 | 2021-01-13 | itchy skin, rash |
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ...
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Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day
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| 41 | 2021-01-13 | itchy skin, swelling, hives |
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea...
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severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-01-13 | injection site pain |
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same p...
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sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
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| 41 | 2021-01-13 | tingling |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-14 | hives, rash, itchy skin |
*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and s...
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*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and swelling on bilateral legs from upper thighs down to feet *Severe Itching Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm. Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
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| 41 | 2021-01-14 | skin spots, hives, injection site pain, injection site swelling |
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,...
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Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
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| 41 | 2021-01-14 | tingling, skin burning sensation |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | vaccination site pain, vaccination site itchiness |
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i...
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Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
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| 41 | 2021-01-14 | vaccination site pain |
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units un...
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Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
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| 41 | 2021-01-14 | tingling |
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was...
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On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
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| 41 | 2021-01-14 | injection site swelling, injection site pain |
Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. A...
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Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain
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| 41 | 2021-01-14 | injection site pain |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | bruising, skin discolouration |
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ...
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Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
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| 41 | 2021-01-15 | itchy skin |
I started itching while being monitored post vaccine administration within the 5 minutes of the vacc...
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I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
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| 41 | 2021-01-16 | itchy skin |
1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted fo...
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1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues
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| 41 | 2021-01-16 | cellulitis, itchy skin, redness |
I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine admi...
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I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine administered it SQ, not IM. I did develop a cellulitis like reaction to the area. The redness began almost immediately following the vaccine, however, the following 2 days the area grew larger and hot to touch. The area currently is red and itchy, however, swelling and warmth is gone. My concern is the efficacy of the vaccine since it was not given IM.
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| 41 | 2021-01-16 | itchy skin, tingling |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-17 | injection site pain, redness, injection site swelling |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | rash | PATIENT PRESENT THROAT ITCH AND SKIN RASH |
| 41 | 2021-01-19 | rash |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who rec...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.
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| 41 | 2021-01-19 | redness |
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati...
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5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
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| 41 | 2021-01-19 | injection site pain | Fever day after vaccine was given along with reaction site pain |
| 41 | 2021-01-19 | injection site pain | Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness |
| 41 | 2021-01-19 | tingling |
NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED...
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NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED AFTER 15 MINUTES
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| 41 | 2021-01-19 | rash |
Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain th...
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Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.
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| 41 | 2021-01-19 | rash | Rashes on right hand. |
| 41 | 2021-01-19 | tingling |
The patient self-reported this adverse reaction through the hospital electronic reporting system. I...
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The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
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| 41 | 2021-01-19 | injection site pain |
at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a he...
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at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a headache in the middle of the night. today i woke up with a lot of pain non my left arm and shoulder and iI put Cbd pain cream all over my arm and tooke paracetamol 650 mlg for pain.
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| 41 | 2021-01-19 | vaccination site pain |
sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a s...
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sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 41 | 2021-01-20 | itchy skin, rash |
Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching ...
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Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | skin infection at injection site, redness |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | tingling |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-21 | injection site pain, injection site reaction |
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ...
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Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
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| 41 | 2021-01-21 | redness, skin infection at injection site |
Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injectio...
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Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)
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| 41 | 2021-01-21 | hives |
Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my sh...
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Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.
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| 41 | 2021-01-21 | injection site pain |
I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle ...
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I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.
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| 41 | 2021-01-21 | hives, itchy skin |
Patient reported to having generalized Itchiness in back, and breast with hives after receiving firs...
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Patient reported to having generalized Itchiness in back, and breast with hives after receiving first shot of vaccine.. After 21 days the patient came to the clinic for the second shot, but she still presented symptoms of the adverse reaction. Dr recommended to do not received the second shot. The patient went to the ER to get a second opinion. After having Talked with Dr, he agree with Dr for to not give her the second shot. Dr. from emergency department proceed to give her Medrol dose pack, Allegra and Zyrtec to relieve the symptoms.
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| 41 | 2021-01-21 | rash, tingling |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-21 | injection site swelling, injection site pain | Soreness at injection site with slight swelling. Fatigue on day 1 following administration. |
| 41 | 2021-01-24 | itchy skin |
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given ...
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Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
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| 41 | 2021-01-24 | tingling |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-24 | itchy skin, rash, hives |
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,...
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Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
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| 41 | 2021-01-24 | injection site pain, injection site redness, injection site swelling, hardening |
I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the inject...
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I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.
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| 41 | 2021-01-24 | tingling |
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ...
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On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
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| 41 | 2021-01-24 | itchy skin |
Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a ...
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Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.
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| 41 | 2021-01-24 | injection site swelling, injection site pain, hives, itchy skin |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-25 | injection site swelling |
20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 mi...
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20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe
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| 41 | 2021-01-25 | itchy skin, hives, redness |
About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, an...
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About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.
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| 41 | 2021-01-25 | rash, itchy skin |
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ...
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Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
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| 41 | 2021-01-25 | hives, itchy skin | Hives, itching, tongue swelling |
| 41 | 2021-01-26 | tingling |
"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. ...
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"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. The next 48 hours the symptoms got worse, and I had paresthesia in b/l upper and lower extremities, my trunk, and my face. My symptoms resolved for 2 weeks, but returned on Jan 10th. They started the same way with numbness and paresthesia in my R great toe and have progressed since them. I'm currently have frequent episodes of paresthesia all over my body and have developed numbness and pain in my hands. I saw my primary physician on Jan 15th regarding the symptoms."
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| 41 | 2021-01-27 | tingling |
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St...
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5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
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| 41 | 2021-01-28 | rash |
Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a sp...
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Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-28 | vaccination site pain |
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T...
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weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
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| 41 | 2021-01-31 | tingling |
10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S wer...
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10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S were taken, HR 80, T97.9, SpO2 98%. BP monitored BP 137/93. Pt observed for additional 15 minutes. Electrolytes given for rehydration. Discharged at 1712. Pt reported feeling better.
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| 41 | 2021-02-03 | tingling |
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo...
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currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-09 | tingling |
Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbnes...
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Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
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| 41 | 2021-02-16 | vaccination site pain, vaccination site swelling |
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ...
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Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-02-21 | hives | During the 15 minute observation period, pt reported upper lip swelling and hives on face. |
| 41 | 2021-02-21 | itchy skin |
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu...
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itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
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| 41 | 2021-02-22 | itchy rash, rash papular, tingling |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-22 | itchy skin |
Patient became itchy. Given 25 mg diphenhydramine suspension. EMS took vital signs and checked BS....
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Patient became itchy. Given 25 mg diphenhydramine suspension. EMS took vital signs and checked BS. Patient monitored from 10:030-11:05.
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| 41 | 2021-02-22 | rash |
Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 d...
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Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 days without improvement
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| 41 | 2021-02-22 | itchy skin, redness |
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi...
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Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
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| 41 | 2021-02-22 | injection site pain, injection site swelling, injection site redness |
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted througho...
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Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
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| 41 | 2021-02-23 | vaccination site warmth, itchy skin |
Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous re...
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Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration (at the age of 41-years-old) on 28Jan2021 15:00 at a single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously took Keflex [cefalexin] and experienced allergy. The patient experienced itching that is spreading across my body and warm sensation at injection site on 28Jan2021 16:00 with outcome of not recovered. Treatment was not received for adverse event. The patient was not pregnant at the time of vaccination. The events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 41 | 2021-02-24 | blister, itchy skin, injection site pruritus |
Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got th...
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Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got the shot on left arm. Wen to bed and woke up next morning it was broken out with blisters all over body, itching everywhere. I went to see my doctor and she hadn?t seen anything like this. I went to the dermatologist they took 3 biopsy?s and came back with a diagnosis of Sweets Syndrome which is an auto immune disorder, paperwork from dermatologist states that it would be favored more likely due to the vaccine. Now I have no job because I cannot work like this, it breaks out or flares up any my allergies flare up or anything that causes my white blood cells to go up.
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| 41 | 2021-03-01 | rash, hives, itchy skin, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | redness, vaccination site warmth |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-09 | injection site pain, injection site rash, tingling |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 42 | 2020-12-31 | itchy skin, injection site swelling, injection site pain, injection site redness |
I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer...
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I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer vaccine, about an inch below the injection site in a wide band across my outer upper arm. It was bad enough that cellulitis briefly crossed my mind bc the redness and tenderness continued spreading for about 24 hrs. It started resolving on post vaccine day 11, but I?m still having mild itching and redness on post vaccine day 12.
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| 42 | 2021-01-01 | injection site redness |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-01 | tingling |
Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, L...
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Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face
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| 42 | 2021-01-02 | sensitive skin |
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive...
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Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
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| 42 | 2021-01-03 | injection site swelling, injection site redness |
After patient received an injection, patient developed fever, body aches, body chills, and injection...
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After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
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| 42 | 2021-01-03 | rash, itchy rash |
Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down ...
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Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.
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| 42 | 2021-01-03 | rash |
Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42...
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Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730 (pending clarification)), intramuscularly at the left arm on 21Dec2020 at 16:00 (04:00 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient's medical history included Diabetic, type 1, allergies to penicillin, and the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient received other unspecified medications within 2 weeks of vaccination. The patient experienced severe rash on 23Dec2020 at 21:30 (09:30 PM). The adverse event resulted in emergency room/department or urgent care: the patient was treated at local ER with prednisone and benadryl. The event was reported as non-serious. The patient recovered from the severe rash on an unspecified date in Dec2020.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of severe rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-04 | injection site swelling, injection site pain |
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz...
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Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
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| 42 | 2021-01-04 | vaccination site redness, vaccination site itchiness, vaccination site swelling |
I had soreness; started with itching, redness and swelling at site of immunization.; started with it...
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I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered. Follow-up attempts are not possible. No further information is expected.
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| 42 | 2021-01-04 | vaccination site pain |
Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site ...
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Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
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| 42 | 2021-01-04 | tingling |
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st...
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Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
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| 42 | 2021-01-04 | injection site swelling |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | hives |
flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contact...
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flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-04 | redness, itchy skin |
itching immediately after injection; then burning; then redness traveling up arm into chest; immedia...
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itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
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| 42 | 2021-01-05 | injection site pruritus, injection site swelling |
12 hours after injection, developed swelling at injection site that increased over two days to be ab...
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12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.
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| 42 | 2021-01-05 | injection site hives |
8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 h...
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8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.
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| 42 | 2021-01-05 | injection site pain | Headache Injection site pain/soreness |
| 42 | 2021-01-05 | injection site pain | Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work |
| 42 | 2021-01-05 | injection site redness | Headache, Myalgia, fatigue,golfball size reddness at injection site |
| 42 | 2021-01-05 | hives, rash |
Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and...
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Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and in groin area; This is a spontaneous report from a contactable nurse (patient herself). A 42-Year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiration date unknown), via an unspecified route of administration at Left arm on 21Dec2020 07:15 AM at single dose for covid-19 immunisation; levothyroxine sodium (SYNTHROID), via an unspecified route of administration from an unknown date at 125ug daily for hypothyroidism. The patient medical history include hypothyroidism. The patient has no known allergies. The patient experienced hives and rash under armpits, up neck, and in groin area on 23Dec2020 with outcome recovered. Events were considered as non-serious with no treatment. The patient has not tested for COVID-19 before or after the vaccination. The action taken in response to the event for levothyroxine sodium was unknown.
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| 42 | 2021-01-05 | injection site hives | delayed urticarial at site of injection, resolved within 24 hours with 1 dose of fexofenadine 180mg |
| 42 | 2021-01-05 | tingling | tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb |
| 42 | 2021-01-05 | vaccination site pain |
vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontan...
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vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
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| 42 | 2021-01-06 | itchy skin, rash, hives |
At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were sw...
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At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.
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| 42 | 2021-01-06 | rash |
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci...
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I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
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| 42 | 2021-01-06 | injection site warmth |
Injection site was at the top of the arm with possible injection into the shoulder joint. Approximat...
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Injection site was at the top of the arm with possible injection into the shoulder joint. Approximately 4 hours after the injection the patient began having severe pain and limited ROM of her shoulder.
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| 42 | 2021-01-06 | injection site warmth, injection site redness, injection site nodule, injection site pruritus |
Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. P...
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Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. Patient developed an itchy, red knot at injection site; 2 inches in diameter and warm to the touch. Patient still has the knot on her arm at the time I am reporting this. She has not taken any medication for it.
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| 42 | 2021-01-06 | itchy skin, redness |
Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphe...
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Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine
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| 42 | 2021-01-06 | rash, tingling, itchy rash |
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re...
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Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
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| 42 | 2021-01-06 | rash, itchy skin |
SkinRash & Rash Narrative: Vaccine on 12/22/2020. That evening at 10:30PM, started w/ itching and ra...
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SkinRash & Rash Narrative: Vaccine on 12/22/2020. That evening at 10:30PM, started w/ itching and rash (erythematous) on chest and abdomen. Resolved with Benadryl 50mg.
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| 42 | 2021-01-06 | itchy skin, hives | UrticariaPruritus SMALL HIVES |
| 42 | 2021-01-07 | injection site pain |
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a...
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1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
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| 42 | 2021-01-07 | tingling, itchy skin, injection site pain, injection site swelling |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | itchy skin, rash |
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait...
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After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
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| 42 | 2021-01-07 | tingling |
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -...
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Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
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| 42 | 2021-01-07 | injection site pain |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | vaccination site pain |
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le...
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Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
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| 42 | 2021-01-07 | sensitive skin |
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;...
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Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
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| 42 | 2021-01-07 | injection site redness, injection site hardening, injection site warmth |
I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the...
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I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the area and has spread a tiny bit and it's warm to the touch with a hard bump. No other symptoms, except tired. no fever ect
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| 42 | 2021-01-07 | injection site warmth, injection site redness |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | injection site redness, injection site warmth |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | injection site redness, injection site warmth |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
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| 42 | 2021-01-07 | hives |
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi ...
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Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
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| 42 | 2021-01-08 | rash | Rash and swelling around mouth, eyes, and behind ears |
| 42 | 2021-01-09 | injection site pain, injection site swelling, injection site redness |
Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enl...
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Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.
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| 42 | 2021-01-09 | redness, hives |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-09 | tingling |
Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscl...
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Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.
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| 42 | 2021-01-10 | tingling |
"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling,...
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"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."
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| 42 | 2021-01-10 | injection site discomfort |
About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down...
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About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
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| 42 | 2021-01-10 | redness, hives |
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and develop...
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After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20
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| 42 | 2021-01-10 | pain of skin, injection site redness | Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain. |
| 42 | 2021-01-10 | rash, itchy skin | Blotchy on chest/face Itching and rash on arms, legs, stomach and hips |
| 42 | 2021-01-10 | hives | Hives, shortness of breath, treated at emergency department with Epinehrine & steriods |
| 42 | 2021-01-10 | hardening, redness | Left axilla pain, left outer arm red, hot, firm. |
| 42 | 2021-01-10 | injection site mass, injection site warmth, injection site redness, injection site pruritus | RED RAISED LUMP AT INJECTION SITE, HOT AND ITCHY ARM. HEADACHE. CHILLS. |
| 42 | 2021-01-10 | itchy skin |
lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, cl...
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lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).
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| 42 | 2021-01-11 | injection site pain, injection site redness |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | injection site pain | Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue |
| 42 | 2021-01-11 | injection site redness, injection site pruritus, injection site swelling |
Large red swollen area on arm were vaccine was given. Redness and area increased the next 3 days aft...
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Large red swollen area on arm were vaccine was given. Redness and area increased the next 3 days after vaccine given, had some blister patches and then itched for 4 days.
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| 42 | 2021-01-11 | rash |
Rash on left arm and right wrist 48 hours after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m...
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Rash on left arm and right wrist 48 hours after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Patient tool cetirizine PO and used triamcinolone cream topically. Appears to have resolved, but no further details in the patient's chart.
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| 42 | 2021-01-11 | injection site redness, injection site swelling |
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa...
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Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
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| 42 | 2021-01-11 | rash |
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she...
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While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm". Â Pt stated that her heart felt like it was "pounding". Â VS: 162/96, 99% RA, HR in the 70's. Â Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home. Â The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist. Â Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications. Â
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| 42 | 2021-01-11 | tingling |
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face...
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Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
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| 42 | 2021-01-11 | rash, itchy rash, hardening |
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo...
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joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 42 | 2021-01-12 | tingling |
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st...
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10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
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| 42 | 2021-01-12 | rash |
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ...
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1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
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| 42 | 2021-01-12 | tingling, injection site tingling |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | hives, skin burning sensation, redness |
About ten minutes after administration I began to feel prickly, burning on my arms which gradually g...
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About ten minutes after administration I began to feel prickly, burning on my arms which gradually got worse over the next 20 minutes and spread to my hands, sides, back and legs. Arms were very red. Informed clinic medical provider who took vitals. blood pressure was 186/116 o2 sat were normal. was given an im shot of benedryl and water, vitals were continued to be monitored and blood pressure came down to 145/84. Prickly burning sensation and redness continued. Went home and examined body and did have several hives on back and upper arm. slept due to benedryl, woke up to a very sore arm, achy joints but the prickly burning had mostly resolved. next day still feel tired and achy in joints but burning is gone.
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| 42 | 2021-01-12 | itchy skin |
Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, las...
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Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, lasting about 24 hrs Day 3: pruitis affecting palms of hands and feet as well as the scalp, ongoing
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| 42 | 2021-01-12 | hives | Hives appeared on day 12 post vaccination. Hives are on right arm and right shoulder blade and chest |
| 42 | 2021-01-12 | injection site pain, injection site swelling |
Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 ...
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Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 1600 noticed under arm swelling and discomfort - thinking it's lymphadenophathy just on left side. Took ibuprofen and no changed as of 1/13 am
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| 42 | 2021-01-12 | tingling |
Patient initially experienced tingling in left hand right after injection. This resolved but then sh...
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Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
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| 42 | 2021-01-12 | injection site pain | weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet |
| 42 | 2021-01-12 | skin spots |
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an...
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wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
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| 42 | 2021-01-13 | skin spots | Development of petechial rash to lower extremities, abdomen and L arm |
| 42 | 2021-01-13 | injection site warmth, injection site pain |
Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the ...
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Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the abscesses became infected with warmth around the site and causing extreme pain. General malaise was felt as well.
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| 42 | 2021-01-13 | injection site pain |
Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pai...
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Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pain, chills, and joint pain on the third day and lasted around six hours. Loss of appetite and nausea lasted about a week. Tiredness and headache lasted almost two weeks.
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| 42 | 2021-01-13 | injection site pain, injection site redness, injection site mass |
Pfizer-BioNTech COVID-19 Vaccine We are reporting a WRONG ROUTE vaccine administration error, NOT a...
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Pfizer-BioNTech COVID-19 Vaccine We are reporting a WRONG ROUTE vaccine administration error, NOT an adverse drug reaction. This occurred at hospital at the vaccine clinic for vaccinating co-workers. The co-worker is a nurse and received first dose of the COVID-19 vaccine 12/19 2020. She reported that the vaccination was given in her right arm, but was administered via subcutaneous route instead of IM. The immunization record shows "IM" as the route administered. Co-worker was concerned about efficacy of the vaccine via SQ route. Physician was made aware and inquired about recommendations for how to proceed. She received the second dose on 1/9/2021 in left arm via IM route. Co-worker did report minor injection site issue - sore, small lump, red, but this is not being reported as an adverse drug reaction; this report is for the wrong route vaccine administration error]
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| 42 | 2021-01-13 | injection site pain, injection site pruritus |
Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including inje...
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Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including injection site soreness, chills, and fatigue over the weekend following the vaccine. The fatigue has been present all week and got worse last night (1/13). Her temperature has been fairly normal since the second dose, but today (1/14), her temperature went up to 100.1 and has been fluctuating throughout the day, staying mostly at about 99.4. States she does not feel sick, but reports feeling "off." Reporting the symptoms because it feels like they are continuing well after receiving the vaccine. Also reports that her arm was a little itchy over the weekend around the area where she received the injection
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| 42 | 2021-01-13 | injection site pain |
Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection s...
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Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection site pain. The symptoms continued until 9 am on 1/14/21 and have now completely resolve. T Max was 102.4 (tympanic).
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| 42 | 2021-01-13 | rash |
The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starti...
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The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.
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| 42 | 2021-01-13 | injection site pruritus, injection site tingling, injection site numbness |
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (...
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Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
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| 42 | 2021-01-13 | redness, hives | URTICARIA, ERITHEMA |
| 42 | 2021-01-13 | tingling |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | injection site pruritus, injection site redness, injection site swelling |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-13 | vaccination site pain |
her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle sore...
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her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle soreness, like from a flu shot; half of the vaccine came out at the injection site and she did not receive the full dose.; This is a spontaneous report from a Pfizer from a contactable nurse reporting for self. This 42-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021) via unspecified route of administration on 06Jan2021 at single dose in left upper arm for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously received her first dose of BNT162B2 (Lot Number: EJ1685) on 18Dec2020 IM in her right deltoid muscle at single dose for COVID-19 immunisation at age of 42-year-old. She said when she received her first dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the vaccine into her right deltoid muscle. She said after receiving the first dose, it was about 9 hours later before her right shoulder hurt. The patient received the second dose on 06Jan2021. She said at least half of the vaccine came out of her arm (came out at the injection site), so she did not receive the full second dose. She said when she received her second dose, the person who administered the vaccine used only a 2- finger width distance from her left shoulder, and administered the vaccine very high up on her left arm. She said her left, upper arm became bruised and sore within an hour after receiving the second dose of vaccine. She said her left arm is still hurting today, clarifying she had a muscle soreness, like from a flu shot. The events did not require a visit to emergency room or physician office. The outcome of events was not recovered. The reporter considered the relatedness of vaccine to all events was related, and considered event her left, upper arm became bruised and sore/ muscle soreness, like from a flu shot as not serious.
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| 42 | 2021-01-14 | itchy skin |
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath...
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10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
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| 42 | 2021-01-14 | tingling |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | tingling |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | injection site pain |
After normal soreness at the injection site, she started with tenderness under in the axillary area....
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After normal soreness at the injection site, she started with tenderness under in the axillary area. States no change in skin; however, is tender to palpate or to have clothes rubbing
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| 42 | 2021-01-14 | tingling | Burning , tingling of arm down to left leg. Burning on back of torso. Numbness down left arm and leg |
| 42 | 2021-01-14 | hives, vaccination site pain |
Hives; Left arm 0.3mL/ sore ness on the arm Left; This is a spontaneous report from a contactable co...
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Hives; Left arm 0.3mL/ sore ness on the arm Left; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (also reported as "41") female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, Expiry Date: 30Apr2021, 3 mcg/ml), via an unspecified route of administration on 08Jan2021 08:40 at 0.3 mL, single dose at left arm ("Dosage text: Left arm 0.3mL") for COVID-19 immunization. Medical history included asthma. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA, reported as "BREO") for asthma. The patient was given 0.3mL, 30mcg of the COVID vaccine. The patient experienced sore ness on the arm left on 08Jan2021 and hives on 09Jan2021. She is calling about the Covid Vaccine, she got it on Friday 08Jan2021 at 8:40AM and she went home got soreness in arm (began the same day), it was a couple hours after at 10 or 11 and it stopped on Sunday 10Jan2021. She took pain killers. She woke up Saturday morning, and her whole body has broken out in hives, she has been taking Benadryl around the clock. She broke out in hives on 09Jan2021, it is still ongoing, its in between, she is still scratching and taking the Benadryl. Therapeutic measures were taken as a result of the events which included pain killers and Benadryl. The outcome of the event sore ness on the arm left was recovered on 10Jan2021, of hives was not recovered. She has never had a positive test for COVID prior to the vaccine. She has had an Antibody test 4 times and each time it was negative, she had her last antibody test in Nov2020. She has had no issues with vaccines in the past.
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| 42 | 2021-01-14 | cellulitis | I developed cellulitis that evening on my right foot. |
| 42 | 2021-01-14 | injection site pain |
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit...
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I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
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| 42 | 2021-01-14 | hives |
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that...
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Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
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| 42 | 2021-01-14 | rash | Red blotchy rash to face and chest |
| 42 | 2021-01-14 | injection site redness |
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O...
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Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
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| 42 | 2021-01-14 | shingles |
Shingles dash developed within 3 days of the vaccine; This is a spontaneous report from a contactabl...
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Shingles dash developed within 3 days of the vaccine; This is a spontaneous report from a contactable nurse (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730, expiration date: not reported), via an unspecified route of administration on the left arm on 18Dec2020 16:45 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cyanocobalamin-tannin complex (B12 [CYANOCOBALAMIN-TANNIN COMPLEX]), ginkgo biloba and colecalciferol (VITAMIN D [COLECALCIFEROL]). Within 3 days of the vaccine, on 21Dec2020, the patient developed shingles rash with outcome of recovered. As treatment, patient received antiviral medication for 7 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Dec2020. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot number was already obtained.
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| 42 | 2021-01-14 | itchy skin, redness | Swelling red tender and very itchy. |
| 42 | 2021-01-15 | tingling |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-15 | rash |
chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and ne...
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chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and neck/chest
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| 42 | 2021-01-15 | injection site pruritus |
fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at inject...
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fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at injection site for 4+ days itching at injection site for 7 days
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| 42 | 2021-01-16 | tingling, injection site hardening |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-16 | injection site pain |
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu...
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On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
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| 42 | 2021-01-17 | itchy skin, hives |
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,...
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About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
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| 42 | 2021-01-17 | tingling |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-19 | itchy skin, injection site pruritus |
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:...
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5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
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| 42 | 2021-01-19 | itchy skin |
About 12 hours after injection I went to bed. No side effects noted during the day. During the nigh...
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About 12 hours after injection I went to bed. No side effects noted during the day. During the night I had insomnia for the entire night. Also noted excessive itching to entire body. No hives or welts. Still itching this morning
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| 42 | 2021-01-19 | redness, injection site pain |
DEVELOPED RED RASH (1" IN DIAMETER). PAIN AT INJECTION SITE. GAVE 25MG DIPHENHYDRAMINE AND MONITORED...
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DEVELOPED RED RASH (1" IN DIAMETER). PAIN AT INJECTION SITE. GAVE 25MG DIPHENHYDRAMINE AND MONITORED FOR 30 MINUTES AND THEN RESOLVED.
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| 42 | 2021-01-19 | injection site pain |
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting...
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EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
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| 42 | 2021-01-19 | hives | Small hives around neck, face, tingling in lips. |
| 42 | 2021-01-19 | hardening | Swollen lymph node under left arm- dime size, hard to touch, tender to touch |
| 42 | 2021-01-19 | itchy skin |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-21 | itchy skin |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | itchy skin, rash |
Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior v...
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Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior vaccination so have MD visit later today for the nausea and rash/itching.
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| 42 | 2021-01-21 | rash | nausea, rash, joint pain, muscle aches |
| 42 | 2021-01-22 | injection site tingling, tingling, injection site pain |
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg...
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At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
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| 42 | 2021-01-24 | injection site pain |
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec...
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12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
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| 42 | 2021-01-24 | injection site warmth, injection site redness, injection site mass, injection site pain, injection site swelling |
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho...
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Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
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| 42 | 2021-01-24 | swelling, hives |
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ...
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No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
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| 42 | 2021-01-24 | vaccination site pain |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | itchy skin | itching and the sensation of shortness of breath on vaccination date of 1/13/21. |
| 42 | 2021-01-24 | tingling |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-25 | rash macular |
Allergic reaction; Red, blotchy rash on face and chest; Red, blotchy rash on face and chest; This is...
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Allergic reaction; Red, blotchy rash on face and chest; Red, blotchy rash on face and chest; This is a spontaneous report from a contactable health professional reported for herself. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1283), via an unspecified route of administration in the right arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included type 2 diabetes, hypothyroidism, and multiple food and med allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is taking unspecified concomitant medication/s (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1283) in the right arm on 21Dec2020 05:00 PM at a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 12:45 PM, the patient experienced allergic reaction of red, blotchy rash on face and chest. The adverse events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient received Benadryl/prednisone as treatments. The outcome of the events was recovering. The events were considered non-serious.
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| 42 | 2021-01-25 | rash, itchy skin | Itchiness throughout body, swollen shots on wrists and under feet, tiny dots on arms Now resolved |
| 42 | 2021-01-25 | itchy skin |
My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then abou...
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My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso. I have little bumps and they itch. It comes and goes.
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| 42 | 2021-01-25 | shingles |
Onset of shingles 16 days after 1st covid vaccine over L1 dermatone, mild discomfort with only a few...
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Onset of shingles 16 days after 1st covid vaccine over L1 dermatone, mild discomfort with only a few vesicles. No prior shingles outbreaks or known triggering factors. Treated with a course of Valtrex
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| 42 | 2021-01-26 | tingling, rash, shingles |
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1...
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Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
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| 42 | 2021-01-26 | injection site redness, injection site swelling, injection site mass |
Patient developed a quarter sized lump at injection site the days after receiving the injection. Thi...
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Patient developed a quarter sized lump at injection site the days after receiving the injection. This was raised and red according to patient's report. It persisted for 4 days and resolved on its own. Patient also developed muscle aches, fatigue, and slight headache. These persisted for 1.5 days.
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| 42 | 2021-01-26 | injection site pruritus |
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti...
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Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
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| 42 | 2021-01-26 | vaccination site redness, vaccination site swelling, vaccination site itchiness |
Swelling and redness and itching at injection site; Swelling and redness and itching at injection si...
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Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; product=COVID 19, brand=Pfizer, dose 1 administration date: 27Dec2020, dose 2 administration date: 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 13Jan2021 at 17:00 at a single dose for COVID-19 immunization. Relevant medical history included thyroid cancer. The patient has no known allergies. Concomitant medications included thyroid (ARMOR THYROID) and ibuprofen (ADVIL). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 27Dec2020 at 10:00 A.M., in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient has not been tested for COVID-19 since vaccination. On 14Jan2021 at 09:00 A.M., the patient experienced swelling and redness and itching at injection site. The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 42 | 2021-01-26 | tingling |
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face ...
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While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly. I immediately took Benadryl when I arrived home and had no further facial symptoms. However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours. After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
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| 42 | 2021-01-26 | tingling |
heart started to race; tingling sensation from her left arm that radiated to all over her body to th...
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heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-28 | rash |
A rash that was located on the neck,chest and back area; This is a spontaneous report from a contact...
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A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.
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| 42 | 2021-01-28 | injection site rash, injection site warmth |
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given...
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c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
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| 42 | 2021-01-30 | rash |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-02-01 | rash | After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke |
| 42 | 2021-02-01 | injection site pain |
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse...
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I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
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| 42 | 2021-02-18 | hives |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | itchy skin, hives | Generalized Pruritic hives |
| 42 | 2021-02-21 | itchy skin, hives |
I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was gi...
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I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.
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| 42 | 2021-02-21 | injection site redness, injection site warmth, injection site swelling, itchy skin |
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i...
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Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
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| 42 | 2021-02-21 | hives, itchy skin, tingling, rash, redness, injection site tingling |
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February...
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Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. Â At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. Â She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. Â Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. Â She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. Â No known history of allergy to polyethylene glycol. Â No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. Â She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. Â She denies any recent medication changes or new over-the-counter medications. Â She has not previously been diagnosed with COVID-19.
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| 42 | 2021-02-21 | hives | hx of hives already which worsened responded to antihistamines-Which resolved. |
| 42 | 2021-02-21 | itchy skin | itching 10 minutes after administration of vaccine no tongue or lip swelling benadryl 50 mg X1 |
| 42 | 2021-02-22 | rash |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-22 | injection site redness, itchy skin |
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injecti...
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Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injection site redness. Vital signs within normal ranges except heart rate 102 beats per minute. Patient administered oral diphenhydramine and observed. Symptoms improved and repeat vital signs all within normal ranges. Patient was discharged from vaccine clinic stable with symptom improvement.
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| 42 | 2021-02-22 | injection site pain | Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High |
| 42 | 2021-02-23 | itchy skin |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-23 | hives, tingling |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-24 | tingling |
Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-ye...
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Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-02-24 | vaccination site pain |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | tingling |
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by ti...
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tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
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| 42 | 2021-02-25 | tingling |
Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneou...
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Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.
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| 42 | 2021-03-02 | vaccination site pain |
Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactab...
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Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.
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| 42 | 2021-03-03 | vaccination site pain |
Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42...
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Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm, on 02Feb2021 at 10:00 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, allergy to animals, allergy to pineapple, and allergy to raw onion. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included levocetirizine dihydrochloride (XYZAL). The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced sore arm at injection site on 02Feb2021 at 17:00. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm at injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 42 | 2021-03-05 | tingling |
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a...
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Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
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| 42 | 2021-03-14 | bruising |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2020-12-31 | injection site pain |
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl...
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Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
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| 43 | 2021-01-02 | vaccination site redness, vaccination site swelling, injection site reaction |
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for...
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Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
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| 43 | 2021-01-03 | hives, hives | Hives |
| 43 | 2021-01-03 | tingling | Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint. |
| 43 | 2021-01-03 | injection site pain |
Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, sh...
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Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
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| 43 | 2021-01-04 | redness |
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned...
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Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | itchy rash, rash |
Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burn...
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Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.
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| 43 | 2021-01-04 | rash |
developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable n...
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developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration into the left deltoid on 18Dec2020 as the first single dose for covid-19 immunization. Medical history was reported as none. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient developed rashes on the chest area, not spreading on 22Dec2020. The event as reported between not serious and medically significant by the reporter. Details were as follows: and patient was a nurse that had her vaccine through her workplace on 18Dec2020, so she was 10 days out, and noticed a rash on her chest on day 4, which was still present. It did not seem to be spreading, and she could not think of any reason for the reaction. She was scheduled to receive the second dose in three weeks. The outcome of developed rashes on the chest area, not spreading was not recovered. The relatedness of the event to the suspect drug was reported as unknown from the reporter.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-04 | rash, shingles |
rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A...
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rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported that a 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced developed a rash and shingles in Dec2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. Information about batch/lot number has been requested.
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| 43 | 2021-01-05 | hives, itchy skin |
Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactabl...
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Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL0140) as the first dose via intramuscular in the left arm on 30Dec2020 11:45 for COVID-19 immunization. Medical history included multiple allergies. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had itching and diffuse hives on 30Dec2020 12:15. Emergency department (ED) evaluation. Diphenhydramine hydrochloride (BENADRYL) and steroids prescribed. The event was reported as non-serious. The outcome of the events was recovering.
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| 43 | 2021-01-05 | vaccination site warmth, vaccination site swelling, vaccination site itchiness, vaccination site redness |
Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse...
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Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse(patient). The 43-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration by injection in the right deltoid on 21Dec2020 at single dose to protect herself from getting COVID. Medical history included ongoing chronic sinusitis , ongoing seasonal allergy. Concomitant medication included ongoing cephalosporin for Chronic sinusitis from 29Dec2020 which was the only thing new that she has been taking, but she had taken it in the past many times, ongoing cetirizine hydrochloride(ZYRTEC) for seasonal allergies, ongoing fluticasone propionate (FLONASE) for seasonal allergies which had been taking this for years. She got her first dose of the COVID vaccine last Monday, the Monday before Christmas on 21Dec2020. Yesterday(30Dec2020), in the exact spot that she received it, she was getting itching, redness, and swelling. She read and was told that that could happen, she just thought it would be sooner rather than 9 days later. She was calling to get this reported. Otherwise, she is fine. She had been using antihistamines and cortisone cream as treatments. She had been taking cetirizine hydrochloride for years. She normally took at night, but because of her arm she took it this morning.Last night(30Dec2020) she also put ice to the are as it felt hot. Outcome of events was not recovered. Events(itching, redness, and swelling) were assessed as non-serious.
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| 43 | 2021-01-05 | tingling |
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet...
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Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
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| 43 | 2021-01-05 | itchy skin | Pt reported itchiness to her body and dizziness. |
| 43 | 2021-01-06 | hives |
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection f...
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Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days
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| 43 | 2021-01-06 | tingling |
I initially developed left arm soreness in the evening of administration of the injection. The follo...
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I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
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| 43 | 2021-01-06 | injection site pain |
Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down wit...
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Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain
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| 43 | 2021-01-06 | hives, itchy skin, redness |
Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzi...
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Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.
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| 43 | 2021-01-06 | rash |
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea ...
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Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
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| 43 | 2021-01-06 | rash |
anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic ...
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anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.
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| 43 | 2021-01-06 | injection site pain, injection site redness | redness pain edema at inj site |
| 43 | 2021-01-06 | injection site pain |
report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and h...
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report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and headache with no fever which she states is tolerable at this time. There was no home remedies. continues to work and She will continue to monitor symptoms
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| 43 | 2021-01-07 | swelling |
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac mo...
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Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
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| 43 | 2021-01-07 | rash |
Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two...
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Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin. The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
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| 43 | 2021-01-07 | injection site pain | FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION |
| 43 | 2021-01-07 | swelling, rash | Fever, Angioedema, SkinRash & Rash Narrative: |
| 43 | 2021-01-07 | itchy skin |
Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrt...
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Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrtec for the itching.
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| 43 | 2021-01-07 | redness, itchy skin |
Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30...
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Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 43 | 2021-01-07 | vaccination site pain |
Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous...
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Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
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| 43 | 2021-01-07 | vaccination site pain, vaccination site swelling |
Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a c...
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Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-07 | redness, cellulitis |
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms ...
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One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
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| 43 | 2021-01-07 | vaccination site pain |
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi...
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Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
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| 43 | 2021-01-07 | hives |
Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1...
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Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine. She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted. Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives. Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
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| 43 | 2021-01-07 | injection site pain, injection site warmth, hardening |
Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm...
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Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. "
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| 43 | 2021-01-07 | itchy skin, rash, hives |
Rash & UrticariaPruritus Narrative: Employee states she took Benadryl, Pepcid and zantac on her own...
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Rash & UrticariaPruritus Narrative: Employee states she took Benadryl, Pepcid and zantac on her own.
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| 43 | 2021-01-07 | injection site pain |
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pai...
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pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
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| 43 | 2021-01-07 | itchy rash, rash | rash on chest and back - light red, mildly itchy |
| 43 | 2021-01-08 | shingles | 5 days after injection trigeminal facial neuropathic shingles, left side of face, C3, r arm, side |
| 43 | 2021-01-08 | injection site pain |
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl...
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Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
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| 43 | 2021-01-08 | hives |
Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet h...
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Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.
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| 43 | 2021-01-08 | tingling | Tingling in right arm that radiated up to cheek and eye |
| 43 | 2021-01-08 | injection site warmth, injection site redness, injection site hardening | the area got hardened, hot and red. |
| 43 | 2021-01-09 | injection site pruritus, injection site redness |
About a day after the shot, I got a red circle a little bigger than a quarter around the injection s...
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About a day after the shot, I got a red circle a little bigger than a quarter around the injection site and the area was very itchy. This lasted several days. I have to assume it was an allergic reaction. Since then it has gone away however I am not sure if I should get the 2nd shot. The vaccine was Pfizer.
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| 43 | 2021-01-09 | hives, itchy skin |
Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swol...
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Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.
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| 43 | 2021-01-09 | injection site pain, injection site swelling | Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site |
| 43 | 2021-01-09 | tingling |
Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening...
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Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening of condition and patient declined further medical care.
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| 43 | 2021-01-09 | redness, hives |
Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benad...
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Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.
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| 43 | 2021-01-10 | tingling |
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle ...
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Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
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| 43 | 2021-01-10 | injection site rash | Diarrhea, lasting 15 minutes. Skin rash at site of injection |
| 43 | 2021-01-10 | redness | Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm |
| 43 | 2021-01-10 | injection site pain |
I had arm pain that radiated from the injection site down to my elbow. I was unable to raise my arm ...
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I had arm pain that radiated from the injection site down to my elbow. I was unable to raise my arm or move it in any direction for 3 days.
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| 43 | 2021-01-10 | itchy skin |
Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the fol...
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Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the following 2 days. The only thing I am allergic to is Neosporin, so I don't know if any of those ingredients are in the Pfizer vaccine.
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| 43 | 2021-01-10 | injection site rash, injection site pruritus |
Itching and rash at injection site. Given IV Benadryl, solumedrol, Pepcid. Rash resolved after tre...
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Itching and rash at injection site. Given IV Benadryl, solumedrol, Pepcid. Rash resolved after treatment.
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| 43 | 2021-01-10 | itchy rash, rash | Itching, rash to bilateral upper extremities, chest, and neck. |
| 43 | 2021-01-10 | itchy skin |
Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on ...
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Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on the day of vaccination, but it got worse the next 2 days. The only medication I am allergic to is Neosporin, so I don't know if the vaccine has components of this in it.
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| 43 | 2021-01-10 | redness | Swelling, pain, muscle weakness, redness, heat |
| 43 | 2021-01-10 | injection site swelling |
injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to clos...
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injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful
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| 43 | 2021-01-11 | injection site warmth, injection site redness, injection site pain, injection site swelling |
After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at th...
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After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at the injection site. The pain and swelling has continued to grow every day until now my arm is swollen from the shoulder to the elbow and around to the inner arm. It is hot, hard to the touch, very swollen, and painful to any touch including clothing. It is now 96 hours later.
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| 43 | 2021-01-11 | tingling |
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho...
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After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
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| 43 | 2021-01-11 | itchy skin |
C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im...
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C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED
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| 43 | 2021-01-11 | rash, injection site redness |
Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external ves...
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Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines
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| 43 | 2021-01-11 | vaccination site redness, rash |
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Sig...
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Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
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| 43 | 2021-01-11 | tingling |
a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand o...
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a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
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| 43 | 2021-01-11 | itchy skin, hives |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-11 | swelling, hives | urticaria angioedema |
| 43 | 2021-01-11 | vaccination site redness, vaccination site warmth, rash |
welt on the injection site that was very hot and red; welt on the injection site that was very hot a...
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welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; rash all over the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 24Dec2020 (as reported) at 07:45 at 43-years-old at a single dose for COVID-19 immunization. Medical history included fibromyalgia, hypertension, and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination). The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced iodine allergy, and codeine (MANUFACTURER UNKNOWN) and experienced codeine allergy; both from an unspecified date to an unspecified date. On 17Dec2020 at 13:15 (as reported), the patient experienced: welt on the injection site that was very hot and red, and rash all over the body. The patient also reported, "I have all the symptoms of COVID-19." It was unknown if the patient received treatment for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test (SARS-CoV-2 test): negative on 04Jan2021. The clinical outcome of the events was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 43 | 2021-01-12 | injection site pain | Chills, upset stomach, soreness at injection site, abdominal gas pain |
| 43 | 2021-01-12 | tingling |
DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED M...
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DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
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| 43 | 2021-01-12 | injection site pain | Fever, Chills, severe body aches, sleepiness, arm soreness at injection site for about 40 hrs. |
| 43 | 2021-01-12 | rash |
I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneou...
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I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose (first dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I want to ask of side effect on Covid Vaccination (captured as Covid Vaccine) because I have already got first dose yesterday and like after few hours I got chills, low fever and the chills, it was like muscle pain, joint pain about today morning it was worse and I am feeling like I have flu already. It is like the same symptoms but muscle, joint pain. I got a little rash on my skin. I ask my doctor he said its better to call them and ask like what's going on that I supposed to do or just wait." The outcome of the event rash and Flu like symptoms was unknown, while the outcome of the other events was not resolved. Information on the lot/batch number has been requested.
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| 43 | 2021-01-12 | injection site rash, injection site pain |
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w...
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I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
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| 43 | 2021-01-12 | hives |
I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anap...
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I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing
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| 43 | 2021-01-12 | bruising |
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9...
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I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
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| 43 | 2021-01-12 | tingling |
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs...
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I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
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| 43 | 2021-01-12 | injection site pain |
Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of...
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Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of the day to the point that it was difficult to use L arm. In addition, there were diffuse body aches, chills and fatigue overnight. Chills resolved by next morning. Body aches and fatigue still present.
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| 43 | 2021-01-12 | rash, itchy skin |
Patient started with rash and pruritus, that started in both hands and then disseminate trough all b...
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Patient started with rash and pruritus, that started in both hands and then disseminate trough all body and face. Pruritus got worst as time passed. The patient visited a medical office and an emergency room at the Hospital. A week after symptoms continues (dermatitis over skin and some pruritus, even with the use of antihistaminic).
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| 43 | 2021-01-12 | injection site swelling, injection site redness |
Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pa...
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Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.
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| 43 | 2021-01-12 | vaccination site itchiness, itchy skin |
felt a little itching around the injection site; she was itching from head to toe; This is a spontan...
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felt a little itching around the injection site; she was itching from head to toe; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2, also reported as COVID 19, brand Pfizer, lot EL1284), intramuscularly in the left arm on 06Jan2021 15:45 at single dose, for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to lima beans, grapes, cucumbers, celery, melons, kiwi. No other vaccine in four weeks. No Covid and Covid test prior to vaccination. Concomitant medications included propranolol, escitalopram, spironolactone, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE), biotin and sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]). The patient previously took CEFTIN (ceftriaxone) and sulfa and had drug allergy. The patient informed that once she got the shot (06Jan2021), she felt a little itching around the injection site a few minutes later. Later on that evening, she was itching from head to toe without any swelling or rash. No treatment was given. The patient recovered from the events.
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| 43 | 2021-01-12 | injection site pain |
soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, musc...
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soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, muscle aches
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| 43 | 2021-01-13 | injection site pain |
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54...
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8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
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| 43 | 2021-01-13 | itchy rash, rash |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | hives, itchy skin |
Employee received 2nd dose of Pfizer vaccine. After about 13 minutes, patient returned to vaccinatio...
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Employee received 2nd dose of Pfizer vaccine. After about 13 minutes, patient returned to vaccination station with complaints of itching and mild hives noted to left forearm. Benadryl 50mg po dispensed at 1345. Pulse Ox: 94%, HR: 70. Pt stated Pulse ox normally runs at this level due to hx of asthma. Itching continued to progress up left arm and down left leg. Denied any reaction after first dose. Vaccine Clinic staff notified. Pt escorted by staff to convenient care at 1353.
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| 43 | 2021-01-13 | rash, rash papular, itchy rash |
I developed a spotty rash on my face and ankle Wednesday afternoon. By the evening, it had spread t...
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I developed a spotty rash on my face and ankle Wednesday afternoon. By the evening, it had spread to my hands and arms. I woke up in the middle of the night and my hands,face,scalp,ears,wrists knees and ankles were covered by a raised blotchy painful , itchy rash. I took a. Claritin, famotadine and a Benadryl with some minor relief. I have not had a formal eval yet.
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| 43 | 2021-01-13 | redness |
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a...
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I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
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| 43 | 2021-01-13 | injection site pain |
Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, ...
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Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, esp L shoulder, L upper back, L neck, L jaw) Joint aches (whole body, esp L shoulder, L jaw) Fatigue Sharp, intermittent shooting pain in shoulder Headache Effects most pronounced night of and day after vaccine, but persisting to lesser degree still on day 3 (today)
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| 43 | 2021-01-13 | injection site pain |
Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had...
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Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had no appetite and had nausea that would come and go. Decreased exercise for a couple days after. The following Monday I still had some fatigue but felt tired and low level nausea and not really hungry, There were waves when I felt like I was coming down with something. I felt tired enough that I went home early from a shift and tested for Covid. Test came back negative.
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| 43 | 2021-01-13 | tingling |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | injection site pain, injection site swelling |
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a...
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Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
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| 43 | 2021-01-13 | itchy rash, itchy rash, rash, rash |
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on...
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We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
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| 43 | 2021-01-13 | itchy skin, redness |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | hives | reported uriticaria and lip/tongue tingling. po benadryl administered. |
| 43 | 2021-01-14 | hives, rash |
07:00 AM six days later 12/24/2020 awoke with hives on the right side of face, neck, and ended u...
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07:00 AM six days later 12/24/2020 awoke with hives on the right side of face, neck, and ended up spreading all over the face, neck, patches on belly and leg. ER . ER treated with 40 IV and oral Prenazone 40 mg for three days 30, for three days then 10 for three days
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| 43 | 2021-01-14 | tingling |
1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and...
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1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and related she was feeling much better
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| 43 | 2021-01-14 | injection site redness, injection site swelling, injection site hardening, injection site pain |
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, ...
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12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms. Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
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| 43 | 2021-01-14 | tingling |
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ...
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15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
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| 43 | 2021-01-14 | itchy skin, rash papular | 3 days of erythematous, pruritic, dry papules on abdomen, axilla, back, neck. |
| 43 | 2021-01-14 | hives, rash |
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ...
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5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
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| 43 | 2021-01-14 | itchy skin, redness |
Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. ...
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Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. Pt. also c/o "tongue tingling." Blood pressure: 192/96, Heart Rate: 78, O2 sats: 97% on room air. Assessed by APN. No Epinephrine or Benadryl given at POD. EMS took patient via ambulance to be evaluated at Medical Center.
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| 43 | 2021-01-14 | hives, itchy skin |
Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given i...
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Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given in ER triage. Caregiver given racemic Epi and another dose of IM Epi in ED. Further care please refer to ED MD
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| 43 | 2021-01-14 | tingling, hives, rash |
During 30 minute observation period patient began to have a rash across their chest consistent with ...
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During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
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| 43 | 2021-01-14 | redness |
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does...
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HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
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| 43 | 2021-01-14 | hives |
Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on fa...
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Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on face after taking ASA lasting for 30 minutes and resolved. Outcome: Continue working did not interfere with ADL's.
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| 43 | 2021-01-14 | itchy skin, hives |
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta...
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Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
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| 43 | 2021-01-14 | vaccination site pain |
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness tha...
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Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
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| 43 | 2021-01-14 | vaccination site pain |
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio...
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Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-14 | injection site redness, hives, injection site pruritus |
Raised welts, redness and itchy around the injection site. Treatment: none. Outcome: does not interf...
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Raised welts, redness and itchy around the injection site. Treatment: none. Outcome: does not interfere with ADLs continue to work.
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| 43 | 2021-01-14 | injection site tingling |
Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports ...
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Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports she had similar reaction when she had gotten the Hep B shot. BP 137/93 HR 92 O2 97%. RR 16. Reports history of HTN. No SOB or tightness of throat. No other symptoms. Sat for 15 more minutes. BP 133/96 HR 88. No further issues except small amount of tingling at shot sites. Patient discharged from clinic with instructions to plan for 1/2 hour sit time with next shot. Any further issues to seek care through PCP.
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| 43 | 2021-01-14 | injection site pain |
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | injection site pain |
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | injection site redness |
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node te...
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approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness. At present, large reddened area at and below injection site and lymph tenderness
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| 43 | 2021-01-14 | vaccination site pain, vaccination site swelling |
tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; mu...
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tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 43 | 2021-01-15 | injection site pain | Fatigue, body aches, headache, injection site pain |
| 43 | 2021-01-15 | rash | Rash, swollen lymph node, fever |
| 43 | 2021-01-15 | redness, hives |
Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vac...
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Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vaccine was injected and the person giving my shot said that she never experienced it before. Arm had a weak feeling. Runny nose as I was being taken down to the emergency room.
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| 43 | 2021-01-16 | tingling |
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l...
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I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
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| 43 | 2021-01-16 | redness, cellulitis |
red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic...
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red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic reaction to COVID-19 vaccine. Was prescribed medrol dose pack and clindymiacin
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| 43 | 2021-01-17 | rash |
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon...
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Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-01-17 | hives, itchy skin, rash papular |
On the morning of 1/12/2021 I had some itching on bilateral elbows and some faint red raised areas o...
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On the morning of 1/12/2021 I had some itching on bilateral elbows and some faint red raised areas on my thighs that were not pruritic. I was able to go to work, however towards the end of the day around 4pm more formal appearing hives appeared on my hands and pruritis increased throughout. I went home at the end of the workday and did a full body skin assessment. I had hives on bilateral arms and legs and several on my face. Pruitis was moderate to severe. I took 50mg of Benadryl and proceeded to the Emergency Department because it seemed to be getting worse quickly and I did not have any other interventions (epi-pen or steroids) on hand at my home.
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| 43 | 2021-01-19 | tingling |
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ...
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1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
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| 43 | 2021-01-19 | injection site pain |
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa...
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Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
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| 43 | 2021-01-19 | injection site pain | Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache |
| 43 | 2021-01-19 | injection site swelling, injection site pain | My right arm at injection site is swollen and hurts and my left side of my face is swollen. |
| 43 | 2021-01-19 | hives, itchy skin |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | injection site hardening |
Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and pred...
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Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and prednisone
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| 43 | 2021-01-19 | rash, itchy rash, injection site pain |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-19 | redness, rash |
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ...
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painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
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| 43 | 2021-01-21 | tingling | Dizziness numbness tingling body aches |
| 43 | 2021-01-21 | tingling | ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS. |
| 43 | 2021-01-21 | rash, hives, redness |
Rash on neck appeared 2nd morning after 2nd Pfizer vaccine given. She noted it really didn't itch u...
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Rash on neck appeared 2nd morning after 2nd Pfizer vaccine given. She noted it really didn't itch unless the area was touched or rubbed. Reported redness, "welps." Improved on its own after 1 week
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| 43 | 2021-01-21 | redness |
Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pi...
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Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pink. Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure". Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732. Discharged home from ED at 1847.
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| 43 | 2021-01-24 | vaccination site pain |
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose...
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Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
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| 43 | 2021-01-24 | sensitive skin |
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev...
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Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
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| 43 | 2021-01-24 | skin burning sensation, rash |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | injection site pain |
patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went ba...
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patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went back up again. patient had muscle aches and joint pains. pain at the injection site. tylenol was given with some relief. patient had severe fatigue for 2 days.
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| 43 | 2021-01-25 | itchy skin, hives |
Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patien...
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Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing prediabetic and hyperlipidemia. Concomitant medication included metformin for prediabetic and pravastatin for hyperlipidemia; both ongoing. The nurse reports that the patient developed hives and itchiness 48 hours after the administration of the first dose. The patient received Benadryl and it is getting better with Benadryl. The outcome of the events was recovering.
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| 43 | 2021-01-25 | vaccination site pain |
Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contac...
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Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-01-26 | tingling |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | tingling |
2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am o...
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2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am on suppression therapy. I have never had one since my initial diagnosis. I also began having numbness and tingling in both feet and hands. The symptoms continued through the second vaccine dose on January 16. The numbness and tingling in my extremities has become worse. An increased dose of Valacyclovir has been ineffective in treating the HSV outbreak symptoms.
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| 43 | 2021-01-26 | hives, rash |
Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous ...
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Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | itchy skin |
Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchin...
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Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchiness progressed to various places mostly around her head and upper torso. She took 50 mg diphenhydramine about 10 minutes after first reporting the symptoms. She reported feeling fine about 1 hour later.
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| 43 | 2021-01-26 | vaccination site warmth |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-27 | injection site bruising |
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin...
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Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
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| 43 | 2021-01-28 | tingling |
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report...
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Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
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| 43 | 2021-01-28 | injection site redness, injection site mass, injection site pain, injection site warmth |
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. ...
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Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
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| 43 | 2021-02-01 | injection site pain |
Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable hea...
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Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable healthcare professional (HCP) (Patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 19:45 at a single dose in left arm for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. No other vaccine in four weeks and no other medications in two weeks. On 16Jan2021, the patient experienced headache, pain at site of injection, chills. No treatment received for events. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information expected.
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| 43 | 2021-02-02 | rash |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-14 | redness |
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne...
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Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-21 | rash |
Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains ...
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Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains on back and traveling up back of neck.
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| 43 | 2021-02-22 | itchy skin |
Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throa...
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Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.
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| 43 | 2021-02-22 | swelling | Swelling of the lips- angioedema |
| 43 | 2021-02-22 | itchy skin |
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f...
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at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
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| 43 | 2021-02-23 | vaccination site pain |
Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous re...
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Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events
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| 43 | 2021-02-23 | vaccination site pain |
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ...
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Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
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| 43 | 2021-02-28 | vaccination site pain |
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have...
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she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-03-01 | blister |
A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The ...
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A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The injection appeared to be low than deltoid and concern it was subcutaneous rather than IM; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: unknown), via subcutaneous route on her right deltoid from 25Jan2021 10:15 to 25Jan2021 10:15 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 04Jan2021 at 10:15 via intramuscular route on her right arm. On 27Jan2021 at 22:00, a blister was noted 2 days after injection that was bigger than a pea but smaller than a dime. The injection appeared to be low than deltoid and concern it was subcutaneous rather than intramuscular (IM). The outcome of the event was recovered on an unspecified date. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
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| 43 | 2021-03-02 | itchy rash |
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci...
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Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-03-14 | hives, rash |
small hives; rash on lower abdomen; This is a spontaneous report from a contactable consumer (patien...
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small hives; rash on lower abdomen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 10Jan2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced small hives and rash on lower abdomen on 19Jan2021 08:00. Therapeutic measures were taken as a result of the events and included treatment with topical cream. Outcome of the events was recovering. The events were considered non-serious. The patient took the second dose of bnt162b2 (lot number: ENS318) in the right arm on 29Jan2021 15:00.
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| 43 | 2021-03-15 | injection site pain |
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 ...
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The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain. Pelvic pain worsened over the next two days 1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain 1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up. 1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss. 1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered 1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size 1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief. 1/29/2021 Pain improved with medication 1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021. 2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit 2/23/2021 Seen at hospital for COVID Preop Testing 2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
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| 44 | 2020-12-31 | redness |
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ...
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After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
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| 44 | 2020-12-31 | rash |
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v...
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Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
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| 44 | 2020-12-31 | injection site nodule, injection site pain, injection site warmth, injection site redness, itchy skin, rash |
itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on si...
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itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,
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| 44 | 2021-01-01 | injection site warmth, injection site rash, injection site pruritus, itchy skin, rash, injection site redness |
At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold ...
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At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold Compress applied to injection site. Later patient reported whole body itchiness and rash that was not raised. Patient is an NP and took prednisone.
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| 44 | 2021-01-01 | hives |
Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG ...
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Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.
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| 44 | 2021-01-01 | injection site redness, injection site bruising, injection site swelling |
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly...
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Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
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| 44 | 2021-01-01 | injection site rash, injection site warmth | ocal allergic reaction warmness rash right at site of injection |
| 44 | 2021-01-02 | rash | rash to torso, back and arms the next day following the vaccine |
| 44 | 2021-01-03 | injection site pain | Arm pain at injection site, fatigue, mild headache, swollen lymph nodes |
| 44 | 2021-01-03 | injection site pain | INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE |
| 44 | 2021-01-03 | skin reaction, tingling | felt hot, prickly, right arm red. Later felt chest tightness |
| 44 | 2021-01-04 | tingling, redness |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | injection site inflammation |
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-1...
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Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.
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| 44 | 2021-01-04 | itchy skin, tingling |
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she...
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Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
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| 44 | 2021-01-04 | vaccination site pain |
Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contac...
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Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself). This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.
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| 44 | 2021-01-04 | redness, itchy skin |
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te...
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pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
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| 44 | 2021-01-05 | injection site pruritus |
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w...
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15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
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| 44 | 2021-01-05 | tingling |
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to ca...
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Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
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| 44 | 2021-01-05 | tingling |
I got the vaccine and three hours later I had both legs below the knee go numb and start tingling ....
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I got the vaccine and three hours later I had both legs below the knee go numb and start tingling . They are still tingling today but the numbness went away the day after I had the vaccine.
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| 44 | 2021-01-05 | vaccination site pain |
Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscl...
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Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | hives, itchy skin |
Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt w...
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Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt was given diphenhydramine IM 25mg Denies SOB, chills, or trouble breathing. Will continue to monitor.
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| 44 | 2021-01-05 | tingling |
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE le...
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Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-05 | vaccination site redness, vaccination site swelling, vaccination site pain |
lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size...
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lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.
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| 44 | 2021-01-06 | rash |
5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed t...
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5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed the rash consistent with herpes zoster, including ophthalmic involvement of the R eye. I have not previously had shingles, but did have varicella as a child. I went to the ER as it was the middle of the night on the weekend and as a physician I realized the eye involvement required immediate treatment. I have since had to see the ophthalmologist x2. The shingles itself is improving, and the eye has healed with steroids and valtrex. I did still receive my 2nd booster shot on 1/5/21 and thus far have not had any additional effects.
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| 44 | 2021-01-06 | injection site redness, injection site pruritus, injection site swelling |
ErythemaMultiform swelling at site of injection Narrative: employee experiencing swelling & redness...
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ErythemaMultiform swelling at site of injection Narrative: employee experiencing swelling & redness in arm apx 10min post injection. vital signs stable at 133/82 HR 78 O2 97% T 98.4 RR16. no further symptoms after 30min monitoring. returned to clinic at 1430 with increased redness/swelling w/new onset of itching near injection site. VS: 138/83 HR 69 O2 96% T99 RR 16. Admin 50mg IV Benadryl. code team arrived and took to ED for further monitoring.
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| 44 | 2021-01-06 | tingling |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-06 | itchy skin, hives, rash |
PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION. PT WAS GIVEN 5...
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PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION. PT WAS GIVEN 50MG BENADRYL. PTS HIVES AND ITCHING STARTED TO FADE ROUGHLY 15 MINUTES AFTER BENADRYL WAS ADMINISTERED. PT HAD NO PROBLEMS BREATHING.
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| 44 | 2021-01-06 | itchy skin |
Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccin...
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Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.
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| 44 | 2021-01-06 | itchy skin |
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and F...
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Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
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| 44 | 2021-01-06 | rash | SkinRash Narrative: |
| 44 | 2021-01-06 | tingling |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-07 | rash |
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu bu...
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Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
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| 44 | 2021-01-07 | vaccination site pain |
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L...
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FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 44 | 2021-01-07 | vaccination site pain |
Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report fro...
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Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report from a contactable consumer. A 44Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Jan2021 at single dose for COVID-19 immunization. The patient did not have medical history or concomitant medications. Patient informed she received the vaccine, her first round of dose yesterday at 2'O clock (02Jan2021) and she was experiencing pain in her shoulder, that was actually throbbing. She also noticed it within a couple of hours, she had a sore throat. Treatment received included Aleve. At the time of the reporting event outcome was unknown. Information on lot/ batch number has been requested.
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| 44 | 2021-01-07 | hives |
Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min. Denied t...
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Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min. Denied throat tightness, or breathing difficulties. Was taken to ED for observation. PMHX includes anxiety, HTN; Meds: Amlodipine, acyclovir; Allergies to Betadine, Erythromycin, Fentanyl, Minocycline, PCN, Versed, and reactions include dyspnea and Hives
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| 44 | 2021-01-07 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject...
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Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
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| 44 | 2021-01-07 | redness |
Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on ...
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Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on its own in 1 hour. Did not need to call physician.
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| 44 | 2021-01-07 | rash, shingles | Severe painful shingle like rash , chills, |
| 44 | 2021-01-07 | rash |
Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020...
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Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020.
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| 44 | 2021-01-07 | tingling |
shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in t...
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shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm. loss of full range of mobility in the shoulder. this has been ongoing x 1 week.
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| 44 | 2021-01-08 | skin burning sensation |
1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my l...
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1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.
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| 44 | 2021-01-08 | rash, itchy rash |
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli...
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1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
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| 44 | 2021-01-08 | rash, itchy skin |
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling i...
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Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
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| 44 | 2021-01-08 | shingles, blister, redness, rash |
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di...
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I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
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| 44 | 2021-01-08 | injection site pain |
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days...
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Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
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| 44 | 2021-01-09 | tingling |
As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is s...
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As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.
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| 44 | 2021-01-09 | injection site pain |
Injection site soreness the following day. That is the only adverse reaction I have experienced thus...
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Injection site soreness the following day. That is the only adverse reaction I have experienced thus far
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| 44 | 2021-01-09 | injection site pain |
Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a ...
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Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a slight fever (37.8 Celsius). Symptoms started 8 hours after the vaccination. No treatment other than strict rest and ibuprofen taken once (600 mg).
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| 44 | 2021-01-10 | injection site pain |
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar...
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1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
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| 44 | 2021-01-10 | skin discolouration |
Both times I received the injection about 48 hours later I had a headache all over my head and naus...
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Both times I received the injection about 48 hours later I had a headache all over my head and nausea. Today I was so nauseous that I vomited about 4 times. I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.
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| 44 | 2021-01-10 | injection site pain, hives, injection site pruritus, injection site redness |
Day after vaccine - red welt, tender, sore, itchy. Took Benadryl and applied ice to area. Pain subsi...
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Day after vaccine - red welt, tender, sore, itchy. Took Benadryl and applied ice to area. Pain subsided after 5 days. 3 weeks after vaccine - large area around site is discolored ( 1 inch bruise in center and redness extends 3 inches around bruise) and itchy.
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| 44 | 2021-01-10 | hives |
Hives on back and stomach, took a Benadryl on 1/10/2021, but the hives came back on the 11th of Janu...
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Hives on back and stomach, took a Benadryl on 1/10/2021, but the hives came back on the 11th of January on my abdomen only.
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| 44 | 2021-01-10 | vaccination site swelling, vaccination site warmth, injection site redness |
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those...
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Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
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| 44 | 2021-01-10 | tingling |
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin...
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Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
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| 44 | 2021-01-10 | injection site pain, redness | Redness, pain injection site, swollen armpit resolved |
| 44 | 2021-01-10 | injection site hardening, tingling, injection site bruising, hives, injection site redness, injection site swelling, injection site pain |
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr...
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Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
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| 44 | 2021-01-10 | injection site pain |
Severe pain at injection site for over 4 days. Severe for the first two days. Took 400 mg Ibuprofen...
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Severe pain at injection site for over 4 days. Severe for the first two days. Took 400 mg Ibuprofen on day4 morning.
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| 44 | 2021-01-10 | redness, itchy skin |
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even ...
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about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
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| 44 | 2021-01-10 | vaccination site pain |
difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fati...
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difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 44 | 2021-01-11 | injection site pain |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | vaccination site pain |
100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body ac...
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100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization. Medical history included high cholesterol. The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021 Information on the lot/batch number has been requested.
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| 44 | 2021-01-11 | pain of skin |
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and...
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24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
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| 44 | 2021-01-11 | redness | Flushing, irregular heart beat, redness on chest |
| 44 | 2021-01-11 | tingling |
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i...
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I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
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| 44 | 2021-01-11 | injection site pain |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | redness, itchy skin |
On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. De...
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On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. Developed pruritus on legs, arms and posterior neck; on 1/10/2020; cannot recall time. w/ scratching becomes red. Took Benadryl last night which caused her to sleep. She reports that she had COVID PCR test performed today through CU, in the bldg. denies other symptoms, SOB, wheeze, rash. recommend that she follow-up w/ her PCP, allergist.
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| 44 | 2021-01-11 | redness |
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ...
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On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
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| 44 | 2021-01-11 | redness, itchy skin, rash |
Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, f...
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Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-11 | tingling |
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo...
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Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
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| 44 | 2021-01-11 | injection site tingling, injection site numbness, injection site warmth |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | shingles |
viral outbreak S1/S2 dermatome, ddx zoster vs. HSV (history of genital HSV). simultaneously had recu...
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viral outbreak S1/S2 dermatome, ddx zoster vs. HSV (history of genital HSV). simultaneously had recurrence of genital HSV.
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| 44 | 2021-01-12 | injection site pain |
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Ty...
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18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
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| 44 | 2021-01-12 | redness, rash |
About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes ...
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About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations. Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.
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| 44 | 2021-01-12 | injection site pain |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | injection site mass | Golf ball sized knot at injection site. Fever |
| 44 | 2021-01-12 | rash, skin burning sensation, shingles |
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Ras...
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Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
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| 44 | 2021-01-12 | hives |
Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ...
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Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
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| 44 | 2021-01-12 | tingling |
The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and...
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The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and left hand. I have never had this happen before. IT lasted for about 15 minutes that night. The day after that(1/9/21), it happened again in the evening and lasted about 10-15 minutes. The morning after that(1/10/21), I had the pins and needles/tingling and a bit of numbness in my left hand that lasted for a few hours. That evening(1/10/21), I had the sensations again in my left hand, as well as noticing a prickling/itching sensation on both of my shoulders. That lasted for about 30 minutes. That was the last time I experienced it and have not experienced it again in the last 2 days.
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| 44 | 2021-01-12 | rash |
The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after...
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The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after I had a very bad headache and a rash on my right arm and shoulder where near proximity of where the shot was given. It was red dots, no itching, no discomfort. I felt feverish as the day proceeded but never had a temperature. The second day after the shot I had the headache the rash was 75% resolved.
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| 44 | 2021-01-12 | shingles, rash, skin burning sensation |
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/202...
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Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
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| 44 | 2021-01-12 | injection site pain, injection site swelling |
employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hou...
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employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hours post receiving second dose of covid 19 Pfizer vaccine on 1/7/2021 in right arm. When questioned the employee stated she also experienced the same mild swelling and tenderness of the armpit area lymph nodes with first dose of vaccine also. The first dose of vaccine was given 12/18/2020 at approximately 1600 in left arm and lymph node mild swelling and tenderness noted in left armpit the following evening. On both occasions the swelling and tenderness lasted 48-72 hours and occurred in the corresponding armpit of the arm which vaccine was administered
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| 44 | 2021-01-13 | itchy skin |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | vaccination site pain |
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;...
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Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
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| 44 | 2021-01-13 | hives |
I received my second dose of the Covid vaccine on 1/12 at 11:00am. At 2:00pm I noticed one large hi...
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I received my second dose of the Covid vaccine on 1/12 at 11:00am. At 2:00pm I noticed one large hive on my right cheek. I did not have any other symptoms or any other hives that I noted on my body.
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| 44 | 2021-01-13 | injection site pain, injection site bruising, injection site redness |
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I ...
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Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
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| 44 | 2021-01-13 | injection site swelling, injection site pain |
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J...
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THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
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| 44 | 2021-01-14 | hives, itchy skin |
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives...
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0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
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| 44 | 2021-01-14 | injection site pain |
1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg ...
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1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg was taken around the clock every 6 hours. It helps with the fever and also for the headache. 1/9/2021 woke up at 4:00 am with vertigo plus the above side effects. In addition to the Tylenol, I had taken dramamine in the morning and had been taking Meclizine 25-50 mg for the dizziness/vertigo. I also had done epley maneuver to help get rid of the vertigo since I am more dizzy turning on my right side and thinks that it is positional vertigo. 1/13/2021 still dizzy and taking Meclizine because it helps for the dizziness. I don't have anymore fever, the pain at the injection site is now mild, still moderate pain for the headache, some body aches but not as much as before. I had gone to the urgent care at this point to be seen since the vertigo is still there since Saturday 1/9 and it is now Wednesday 1/13. The doctor at the urgent care told me to continue taking Meclizine, hydrate and rest for a total of one week since the onset of the vertigo.
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| 44 | 2021-01-14 | tingling |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | rash |
I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my ski...
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I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my skin). I developed left supraclavicular lymphadenopathy on 12/25 and that is still present and unchanged. I reported that prior. I developed a rash similar to pityriasis rosea on 1/11. This is progressive and still present. I do currently also have fatigue and possible conjunctivitis.
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| 44 | 2021-01-14 | pain of skin |
Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderne...
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Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderness of dermal filler which was placed in Dec2019.; first dose 20Dec2020/second dose 06Jan2021; This is a spontaneous report from a contactable physician (patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Dec2020 11:45 then received the second dose on 06Jan2021 14:30, via an unspecified route of administration on the right arm at single dose for COVID-19 immunization. Medical history included allergic rhinitis, depression and gastrooesophageal reflux disease (GERD); all from unknown dates. On Dec2019, patient was placed with dermal filler. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and omeprazole. On 08Jan2021 07:00, the patient experienced inflammation and tenderness of dermal filler which was placed in Dec2019. No therapeutic measures were taken as a result of the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-01-14 | itchy skin, hives | Itching/hives over head, ears, no breathing difficulty |
| 44 | 2021-01-14 | injection site hives, injection site redness, injection site warmth | Large, warm, red hive, size of entire arm directly surrounding injection site. |
| 44 | 2021-01-14 | rash, itchy rash |
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o...
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Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
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| 44 | 2021-01-14 | itchy skin |
Pt reported feeling itchy "all over" 19 minutes post vaccination. She denied any other sxs such as S...
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Pt reported feeling itchy "all over" 19 minutes post vaccination. She denied any other sxs such as SOB, throat tightness, difficulty swelling, lightheadedness, nausea, vision change. I checked her BP and pulse @ 1117 and again @ 1122. Her BP and pulse remained stable and in normal range. Her lungs were clear, no wheezing. There was no visible rash. I administered 25 mg of benadryl @ 1125. She left the clinic 35 minutes post vaccine in good condition without evidence of significant reaction.
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| 44 | 2021-01-14 | hives, itchy skin, rash |
Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolv...
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Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolved after 24 hrs Rash/hives and itching continue
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| 44 | 2021-01-14 | injection site redness, injection site mass |
Redness around the injection site approximately the size of a half dollar. Also, a knot at the injec...
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Redness around the injection site approximately the size of a half dollar. Also, a knot at the injection site.
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| 44 | 2021-01-14 | rash macular |
red blotches on my arms and upper chest; This is a spontaneous report from a non-contactable other h...
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red blotches on my arms and upper chest; This is a spontaneous report from a non-contactable other health care professional. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose at arm left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Jan2021, the patient experiencing red blotches on my arms and upper chest. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-01-15 | injection site swelling, injection site redness |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-15 | injection site pain |
Have pain to site and worsening to the point where I have to use my right arm to move my left one. ...
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Have pain to site and worsening to the point where I have to use my right arm to move my left one. Not moving it much since 1/15/21
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| 44 | 2021-01-15 | tingling |
Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe i...
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Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11
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| 44 | 2021-01-16 | itchy skin, rash, hives | Egan as itchiness, still extreme itchiness with welts and rash over entire body |
| 44 | 2021-01-17 | hives |
Patient had Pfizer vaccine and came in with Mild urticaria and hives after receiving COVID vaccine M...
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Patient had Pfizer vaccine and came in with Mild urticaria and hives after receiving COVID vaccine Mild urticaria and hives after receiving COVID vaccine, with no signs of anaphylaxis or shock and no indication for medication administration (e.g. epinephrine, diphenhydramine). Symptoms spontaneously resolved. Tryptase level was 6.7 ug/l (within normal limit). Patient discharged in stable condition. Further follow up showed that patient is feeling fine after allergic reaction. Plan is underway to schedule for the second vaccine, although they have tentatively told her that she will get her second dose in the allergy clinic. Possible this was due to the vaccine given the proximity of timing and adverse event but since the second dose will be given in allergy clinic, the pt will be monitored closely.
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| 44 | 2021-01-18 | rash, hives |
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev...
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Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-19 | rash |
ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CH...
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ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CHEST, UPPER BACK AND STOMACH STARTING 2ND DAY AFTER VACCINE. LASTED A LITTLE LESS THAN 24 HRS. TOOK TYLENOL AND MOTRIN
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| 44 | 2021-01-19 | injection site swelling, injection site pain |
Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pa...
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Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pain & swelling
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| 44 | 2021-01-19 | injection site rash, injection site redness, injection site pruritus, injection site warmth |
On Day 4 post injection, I developed a 4 inch vertical by 2 inch across red "splotch" rash at the in...
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On Day 4 post injection, I developed a 4 inch vertical by 2 inch across red "splotch" rash at the injection site on my left arm, which was hot to the touch. On Days 5 and 6, it is no longer red, but it itches. This Day 4 "splotch" rash was visible and I took a picture and sent it to my doctor and she told me to report it to you. It was no longer visible when I woke up yesterday on Day 5 post injection. I am going to keep monitoring it and see if I have any symptoms that get worse, because I have had adverse reactions to flu shots twice in past.
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| 44 | 2021-01-19 | hives |
Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team ...
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Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives). Patient was counseled by lead pharmacist regarding risk and and data related to vaccine. Patient agreed to receive vaccine. Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay. Patient was observed by nursing. At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech. She has administered 50mg Benadryl suspension. Vital signs taken: 1900: 147/92; 82; 97% room air 1905: 132/101; 84; 97% room air 1910: 145/104; 84; 97% room air. 1915: 147/104; 81; 97% room air RN observer called vaccine physician on call at 1915 regarding patient status. Patient was then observed to have hives around her neck, upper chest and arms. RN then called again at 1924. Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine. Pharmacist pulled up 0.3mL of epinephrine. Administered injection in right thigh at 1934. Ambulance called and arrived on site at 1936. Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
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| 44 | 2021-01-21 | injection site pain, hives |
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes...
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48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
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| 44 | 2021-01-21 | injection site pain |
AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTIO...
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AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTION SITE
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| 44 | 2021-01-21 | itchy skin |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-21 | tingling |
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c...
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Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
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| 44 | 2021-01-21 | injection site pain |
woke up with left sided chest pain and thought she may be having an MI; Injection received in left a...
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woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-24 | bruising |
A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down m...
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A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down my right forearm. I initially thought it was a bruise but don't recall hitting my arm in such a violent way to create this big purple mark on my arm. After weeks-the mark is still there and is not fading. I've also been getting short flashes of headaches that I don't recall experiencing in the past.
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| 44 | 2021-01-24 | sensitive skin |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-25 | rash |
Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximatel...
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Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximately 160-170s. Then about 40 hours after vaccination a rash developed. Previous history of viral rashes. Rash covered front and back of trunk took benadryl but lasted approximately 2 days. Lastly, on 1.25.2021, had a CT with contrast for another medical concern (not related) ended up having an allergic response to the contrast. Has had multiple CT over the years (greater than 10) has never had a reaction.
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| 44 | 2021-01-25 | vaccination site pain |
joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a ...
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joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a contactable nurse. A 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm right, on 13Jan2021 14:15 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2, intramuscular in arm right, on 23Dec2020 13:15 at single dose for covid-19 immunisation. The vaccine was administered at Physician Office. No other vaccine was administered in four weeks. COVID was not tested post vaccination. No known allergies. Medical history included migraines from an unknown date and unknown if ongoing. The patient had COVID prior vaccination. The patient's concomitant medications included butalbital, caffeine, paracetamol (FIORICET). On 13Jan2021 the patient experienced joint pain, chills, headache, severe injection arm pain, fever. The patient was treated for the events with OTC fever and pain reducer and IBUPROFEN. The outcome of the events was resolving. Information on the lot/batch number has been requested.
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| 44 | 2021-01-26 | itchy skin, hives |
Itching, Hives to neck and back; Itching, Hives to neck and back; This is a spontaneous report from ...
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Itching, Hives to neck and back; Itching, Hives to neck and back; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EK9231), via an unspecified route of administration on right arm at 08:45AM on 12Jan2021 at single dose for COVID-19 immunization. Medical history included hashimotos thyroid, mild exercise and allergy induced asthma, Allergies: Penicillin, Allergies: mold, Allergies: ragweed, Allergies: coconut, citrus. Concomitant medication included thyroid (ARMOUR THYROID), colecalciferol (VITAMIN D), vitamin c [ascorbic acid]. The patient previously received her first dose of bnt162b2 (Lot number=EK5730) at 09:00 AM on 22Dec2020 on right arm for COVID-19 immunization, PABA and experienced drug hypersensitivity. The patient experienced itching, hives to neck and back noted 25-30min after receiving vaccine at 09:15AM on 12Jan2021. Observed in vaccine clinic, vitals stable. Took Claritin 40min after vaccine. Hives resolving, no new symptoms at 90min post vaccine. Hives did return the next day when Claritin dose wore off; took another dose with Hives resolving within 2hours. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering.
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| 44 | 2021-01-26 | injection site discomfort |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | itchy skin, hives |
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Vis...
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Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
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| 44 | 2021-01-26 | itchy skin |
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat...
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Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
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| 44 | 2021-01-26 | injection site pruritus, injection site redness, injection site hardening | Small lump and redness and itching at injection site |
| 44 | 2021-01-26 | vaccination site pain |
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c...
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arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
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| 44 | 2021-01-26 | vaccination site pain | headache, lightheadedness, fatigue, joint pain, diarrhea, normal vaccine site tenderness, chills |
| 44 | 2021-01-26 | hives, blister, rash |
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue...
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surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-26 | rash, shingles |
was not ill prior to vaccine. 3 days later started getting rash on neck. went to doctor was told it ...
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was not ill prior to vaccine. 3 days later started getting rash on neck. went to doctor was told it was shingles. never had any warning signs of shingles. I had just had a complete health check a couple months prior and everything was OK.
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| 44 | 2021-01-27 | itchy skin, hives |
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel...
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1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
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| 44 | 2021-01-27 | injection site pain |
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T...
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her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
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| 44 | 2021-01-28 | rash, hives |
1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash o...
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1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
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| 44 | 2021-01-28 | rash | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | hives | Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out |
| 44 | 2021-01-28 | vaccination site pain |
I developed a painful burning rash below the injection site; I developed a painful burning rash belo...
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I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; It appears my skin is beginning to peel as well. It remains painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), via an unspecified route of administration in the left arm on 15Jan2021 at 2:30 PM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), intramuscular, left arm on 29Dec2020 for COVID-19 immunization. On 17Jan2021, approximately 48 hours after, the patient developed a painful burning rash below the injection site. It appears her skin is beginning to peel as well, it remains painful to touch. Treatment with over the counter (OTC) medicine was taken as a result of patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch. The clinical outcome of the events patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-28 | skin burning sensation |
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou...
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The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
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| 44 | 2021-02-08 | injection site swelling, injection site pain |
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle...
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Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
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| 44 | 2021-02-08 | skin infection at injection site |
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic ther...
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cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-21 | rash |
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ...
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1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
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| 44 | 2021-02-21 | injection site pain |
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that...
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About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
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| 44 | 2021-02-21 | injection site pain |
Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm...
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Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
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| 44 | 2021-02-21 | rash |
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai...
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Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
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| 44 | 2021-02-21 | shingles, rash | Shingles developed on the right upper back 3 weeks after the rash |
| 44 | 2021-02-21 | pain of skin |
Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report fr...
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Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation. Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing. Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine. The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-21 | rash |
Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx resolved after 4 days later. Then 5 da...
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Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx resolved after 4 days later. Then 5 days later developed rash to bialteral arms and gluteal region, resolved at the end of day.
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| 44 | 2021-02-22 | injection site pain | Sore arm at injection site and fatigue |
| 44 | 2021-02-22 | redness |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
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| 44 | 2021-02-22 | rash, itchy skin |
patient had itching of hands My symptoms were were primarily mild itching in the palms and throat an...
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patient had itching of hands My symptoms were were primarily mild itching in the palms and throat and a rash on my chest and hands (was wearing a jacket and mask). On an itching scale of 1 to 10, I told them 2 to 3. According to my nurse, the rash on my chest and hands seemed to peak around 15-20 minutes after (not crimson) and when I finally got to go to the bathroom at the one hour mark and check myself in the mirror
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| 44 | 2021-02-25 | vaccination site redness |
BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a c...
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BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9265), via an unspecified route of administration on 12Feb2021 16:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 05:00 PM at left arm at age of 44 years old with lot number EL1283. Patient is not pregnant at the time of vaccination. The facility type vaccine was Doctor's office/urgent care. The patient medical history was not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included omeprazole, levothyroxine, montelukast sodium (SINGULAIR). The patient experienced BCG vaccine site/mark became red on 14Feb2021 after 2nd dose. No itching as of now. Did not happen after 1st dose. It's been red for few hours now. There was no treatment received for the adverse event. The outcome of event was unknown. The event was reported as non-serious.
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| 44 | 2021-02-28 | injection site pruritus, injection site hives, injection site redness, redness, itchy skin, rash, hives, injection site rash |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | vaccination site redness, vaccination site swelling, vaccination site pain |
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle...
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injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
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| 44 | 2021-03-02 | tingling |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | rash |
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation...
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Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
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| 44 | 2021-03-04 | tingling |
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l...
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Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
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| 44 | 2021-03-09 | rash, hives |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-09 | vaccination site pain |
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injection...
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lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-10 | rash macular |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | hives |
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on...
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dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-17 | redness |
Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red ...
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Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
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| 45 | 2020-12-31 | injection site redness, injection site bruising, injection site warmth, injection site pruritus |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2020-12-31 | redness |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2021-01-01 | redness |
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt...
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Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
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| 45 | 2021-01-01 | tingling |
Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm ...
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Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.
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| 45 | 2021-01-03 | redness, itchy skin |
2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at t...
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2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck I had vaccine on 12/30/20 at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
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| 45 | 2021-01-03 | tingling |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-03 | injection site pain |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-03 | tingling | Tingling of face for a couple hours, starting 2 hours after vaccine, gone by the next day |
| 45 | 2021-01-03 | itchy skin | itching both thighs, mild h/a, sinus pressure |
| 45 | 2021-01-04 | tingling |
Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle...
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Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.
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| 45 | 2021-01-04 | cellulitis, redness |
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ...
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Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
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| 45 | 2021-01-04 | tingling |
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin...
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Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
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| 45 | 2021-01-04 | tingling |
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ...
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Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
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| 45 | 2021-01-04 | redness |
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou...
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Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
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| 45 | 2021-01-04 | rash, itchy skin |
itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This...
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itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-01-05 | itchy skin |
ABOUT 1020 25 MINUTES AFTER VACCINE ADMINISTRATION PATIENT FELT ITCHY ALL OVER BODY. PATIENT DESCRI...
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ABOUT 1020 25 MINUTES AFTER VACCINE ADMINISTRATION PATIENT FELT ITCHY ALL OVER BODY. PATIENT DESCRIBES ITCHING AS MODERATE. NO RASH NOTED. NO ANGIOEDEMA. PATIENT NO IN RESPIRATORY DISTRESS. 1028 VITALS: BP: 172/93 P: 62 SAO2: 99%. BENADRYL 50MG ORAL GIVEN AT THIS TIME. 1038 VITALS: BP: 155/99 P: 64 SAO2: 99% PATIENT DESCIBES ITCHING AS THE SAME, MODERATE. NO REDNESS AT SITE, NO RASH, NO RESPIRATORY DISTRESS. 1048 VITALS: BP: 164/108 P: 63 SAO2: 99% PATIENT TAKEN TO ER
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| 45 | 2021-01-05 | itchy skin |
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ...
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Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
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| 45 | 2021-01-05 | injection site redness, injection site pain |
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br...
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[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
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| 45 | 2021-01-06 | tingling, rash |
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte...
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Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
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| 45 | 2021-01-06 | hives | DIffues hives over chest, abdomen, back, arm |
| 45 | 2021-01-06 | tingling |
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. ...
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I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
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| 45 | 2021-01-06 | injection site mass |
Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at sit...
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Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at site. Applied ice and heat. States it is getting better but if "ball" does not get any better would like to be seen. Agreed with aptient
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| 45 | 2021-01-06 | itchy skin, rash |
Rash Narrative: Employee received Covid 19 vaccine (Pfizer) at 2:30 pm, developed rash 4:30pm, pres...
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Rash Narrative: Employee received Covid 19 vaccine (Pfizer) at 2:30 pm, developed rash 4:30pm, presented to clinic on 12/30/2020 rash still present with some itching. Seen by MD advised Benadryl and to seek medical attention for any increase in symptoms such as SOB.
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| 45 | 2021-01-06 | rash macular, rash | SkinRash chills Narrative: macular rash over the trunk anterior chest, abdomen, back and both arms |
| 45 | 2021-01-06 | tingling, injection site pain |
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti...
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Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
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| 45 | 2021-01-07 | itchy rash, injection site redness, injection site warmth, itchy skin, rash |
11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right aft...
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11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right after I saw that, I took a shower and minutes after a shower I developed red itchy rash all over my arms and legs. Then my abdomen and back started to itch as well. Immediately I took 50 mg of Benadryl and went to sleep. Itch continued while I was trying to fall asleep. In the morning there was no rash on my body except for a small redness on my injection site. By the way, with the first shot that I had on December 19, 2020, Pfizer Lot # EH9899 in the same facility , I developed red, hot to touch, not raised rash all over my deltoid muscle of the left arm 2 days after the shot was administered and it lasted for 3 days with no change. Benadryl and Allegra did not help with shot # 1.
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| 45 | 2021-01-07 | redness |
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a...
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Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-07 | injection site pain |
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: V...
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Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
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| 45 | 2021-01-07 | shingles |
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain o...
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I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
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| 45 | 2021-01-07 | vaccination site pain |
My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me a...
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My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 18Dec2020 at 06:15 a.m., at single dose, for COVID-19 immunization. The patient has no relevant medical history. Concomitant medications included vitamins and calcium chews (one a day) and cetirizine hydrochloride (ZYRTEC). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine four weeks prior vaccination. The vaccine was administered in the hospital. On 01Jan2021, the arm where patient received the shot was now hurting more. Patient can't lift her arm up out in front of her and straight up in the air. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 45 | 2021-01-07 | rash |
Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVI...
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Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/7/2021  Date: 1/7/2021  Subjective Patient is a 45 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the left deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt took allegra this am for allergies.  ALLERGY REVIEW OF SYSTEMS: All other systems negative   Previous Reactions: She states with first shot a few hours after her shot she had a rash on her mid back. and and lower extremities. Pt also had a head ache. Symptoms lasted 5 days.   Objective  Vitals Vitals:  01/07/21 1248 01/07/21 1303 01/07/21 1321 01/07/21 1334 BP: (!) 150/87 130/71 137/87 123/73 Pulse: 94 86 75 76 SpO2: 97% 99% 98% 99%     Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (on chest) present. Rash is macular. Comments: Flushing over the cheeks and bridge of the nose. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.Pt told if symptoms worsen or changed she is to be seen in the ER.  Diphenhydramine 25 mg oral given at 12:55pm.  Pt okay to go home with dad driving at 14:22 pm.   Electronically Signed 1/7/2021 2:03 PM   Â
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| 45 | 2021-01-07 | itchy skin |
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started...
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Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
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| 45 | 2021-01-07 | itchy skin | Pfizer-BioNTech COVID-19 Vaccine EUA, Itching that started about 3 minutes |
| 45 | 2021-01-07 | rash | Rash present at the top of the neck that appeared 30 minutes after vaccination |
| 45 | 2021-01-07 | redness | Redness on face, neck, and arms, Tachycardia, HTN |
| 45 | 2021-01-07 | injection site pain |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
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| 45 | 2021-01-07 | injection site pain |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
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| 45 | 2021-01-07 | tingling |
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th...
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minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
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| 45 | 2021-01-07 | vaccination site pain |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-08 | hives | Hives 14 days post injections |
| 45 | 2021-01-08 | itchy skin |
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm...
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I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
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| 45 | 2021-01-08 | itchy skin, redness, rash |
SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between ...
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SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between the eyebrows). Hx. seasonal and alcohol allergies that present with rash Narrative: c/o itchiness of the lower back. redness noted on the lower back and the forehead (between the eyebrows). No sob. states hx/seasonal and alcohol allergies that present with rashes. Benadryl given @ 1650: 156/86, 86, 95%O2sat. @ 1700: 163/89, 81, 97%O2sat; @1720: 163/89, 91, 98% O2sat. 1720 redness diminishing, redness to forehead almost gone. In good spirits and denies sob. D'c'd stable to home with friend to escort. Going home, husband home, per pt.
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| 45 | 2021-01-08 | injection site pain |
Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 ...
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Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 (hiccups are not something that I normally get, if I do I only hiccup 3-4 times on average
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| 45 | 2021-01-09 | injection site rash, injection site pain |
18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of inj...
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18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of injection and neck. Subsequently developed flu-like symptoms: headache, fever(101F), chills, myalgias, arthaligias, fatigue that continued daily for several weeks.
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| 45 | 2021-01-09 | hives |
No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hiv...
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No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hives head to toe. I took pictures if you need them.
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| 45 | 2021-01-09 | rash, hives |
on day of injection approx 13 mins after injection RN was called to her car. She reported throat tig...
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on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.
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| 45 | 2021-01-10 | injection site redness, injection site pain, injection site swelling, injection site pruritus |
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injecti...
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HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
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| 45 | 2021-01-10 | injection site pruritus, injection site warmth, itchy skin, injection site swelling |
Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swel...
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Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swelling and itching continued to get worse. Site was hot. Stared taking Zyrtec twice a day. Within 48 hours site was so swollen visible through clothes, like a plum under the skin and was hot, itching. 99.5 temp Added Pepcid on Sunday, Swelling started going down, better Monday morning.
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| 45 | 2021-01-10 | hives, itchy skin |
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an...
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Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
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| 45 | 2021-01-10 | injection site redness, injection site pain, injection site warmth | Pain, redness and streaking, warmth at injection site, seen in ED and prescribed doxycycline. |
| 45 | 2021-01-10 | redness, itchy skin |
Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccina...
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Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccination. Patient reports having taken Benadryl 25 mg PO on her own approximately 1 hr before receiving the vaccine. Another Benadryl 25 mg PO x1 dose adminstered at 9:05am. BP 162/80 HR 64 O2=96% at 09:20am. Lip numbness being reported at 9:20am. Itching subsiding at 9:30am. Patient clinically stable. Patient released from clinic at 9:30am. Patient also reports itching and redness with 1st dose of Pfizer COVID-19 vaccine. Patient also reports having Bell's Palsy after receiving the 1st dose of Pfizer vaccine (with photographic evidence) that was noticed approximately 11 hours after 1st dose of vaccine administration. Patient realized she was having Bell's Palsy after she began noticing having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days) prescribed by her physician. Bell's Palsy resolved in approximately 6 hours.
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| 45 | 2021-01-10 | injection site swelling, injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10...
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Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10, injection site swelling
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| 45 | 2021-01-10 | redness |
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv...
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Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
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| 45 | 2021-01-10 | redness |
Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day a...
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Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day at work. Face turned red, needed to change her clothes the sweating was so bad.
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| 45 | 2021-01-10 | hives | Swollen lips and face hives on face |
| 45 | 2021-01-10 | injection site pain, injection site redness | redness, pain on arm resolved |
| 45 | 2021-01-11 | redness, itchy skin, rash macular |
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ...
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A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
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| 45 | 2021-01-11 | rash macular |
Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after ...
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Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after I had waited my 15 minutes I left and it happened in the car and notified the person that gave me the injection and was told to go to Emergency Room. Was told by Emergency Room that I should not have had the injection being allergic to bee stings. Was given IV with Steroid. Discharge papers said Allergic reaction to drug.
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| 45 | 2021-01-11 | redness |
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ...
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Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
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| 45 | 2021-01-11 | vaccination site pain, tingling, vaccination site itchiness, vaccination site swelling |
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ...
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Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
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| 45 | 2021-01-11 | redness, rash, itchy skin, injection site pain |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-12 | tingling, redness |
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a...
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12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
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| 45 | 2021-01-12 | swelling |
23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurren...
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23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurrence of angioedema in lips. A 3rd occurrence took place 1/12/2021 and this occurrence was most severe of the 3 occurrences so far.
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| 45 | 2021-01-12 | injection site redness, injection site pruritus, injection site swelling | Chills, joint pain, redness/swelling/itching at injection site |
| 45 | 2021-01-12 | hardening, redness, blister | HOT, HARD RED AREA, BLISTERING, PAINFUL |
| 45 | 2021-01-12 | rash, hives | Hives covering most of body; began 2-3 hours after injection; bloody diarrhea. |
| 45 | 2021-01-12 | injection site warmth, injection site hardening, injection site redness |
Left arm at injection site is red (size of an apple), hard and warm. My provider drew a circle arou...
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Left arm at injection site is red (size of an apple), hard and warm. My provider drew a circle around the redness to see if it gets bigger 01/13/21
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| 45 | 2021-01-12 | rash | Patient developed a rash from the neck up. |
| 45 | 2021-01-12 | itchy skin |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
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| 45 | 2021-01-12 | itchy skin |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
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| 45 | 2021-01-12 | blister, rash | Rash all over body with swelling and blisters |
| 45 | 2021-01-12 | injection site redness, injection site swelling, injection site pain, injection site pruritus |
Swelling, redness, itching and burning radiating out from injection site starting two days after, in...
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Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
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| 45 | 2021-01-12 | injection site rash | Systemic: Rash (other than injection site)-Mild |
| 45 | 2021-01-12 | injection site nodule, redness |
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a...
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The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
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| 45 | 2021-01-13 | rash, tingling |
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra...
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Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
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| 45 | 2021-01-13 | rash |
Associate reported to Employee Health on 01/13/2021 that she experienced a rash on her arms and legs...
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Associate reported to Employee Health on 01/13/2021 that she experienced a rash on her arms and legs on 01/08/2021. Patient reported that the rash was present after her first vaccination on 12/18/2020, but she did not report her reaction to Employee Health. After her second dose of COVID19 vaccine the rash re-appeared and spread from her legs to her arms. Employee Health encouraged her to follow up with her medical provider. Rash was still present as of 01-13-21.
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| 45 | 2021-01-13 | itchy rash, rash |
Bumpy itchy rash the began with a few bumps on right thigh 4 days ago and has progressed to bumpy it...
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Bumpy itchy rash the began with a few bumps on right thigh 4 days ago and has progressed to bumpy itchy rash covering entire leg hip to ankle bilaterally
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| 45 | 2021-01-13 | injection site swelling, injection site pain |
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC...
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FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
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| 45 | 2021-01-13 | hives | Hives occured 15 mins after vaccination Patient took diphenhydramine 25 mg |
| 45 | 2021-01-13 | itchy skin |
Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient re...
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Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, intramuscularly in the right arm on 08Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to peanuts and shellfish, COVID-19 on an unspecified date (reported as a COVID-19 diagnosis prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Jan2021 (reported as 3 minutes after receiving the vaccine), the patient experienced itching. The patient was treated with diphenhydramine (BENADRYL) 50 mg for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "itching" was not resolved.
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| 45 | 2021-01-13 | injection site pruritus, injection site pruritus |
Recieved the vaccine at 4:30pm; at 4:40, injection site became very itchy; Associate was advised to ...
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Recieved the vaccine at 4:30pm; at 4:40, injection site became very itchy; Associate was advised to take Benedryl p.o.; discharged home. No signs of visible distress following administration and prior to discharge
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| 45 | 2021-01-13 | skin burning sensation |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | tingling |
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal an...
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About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm. Vital signs within normal limits. Improved
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| 45 | 2021-01-14 | injection site pain, injection site swelling | Approx 10-12 hours after dose: injection site pain, swelling, headache, fever (temp max 99.5) |
| 45 | 2021-01-14 | rash, rash papular, itchy skin, redness |
Erythema, raise, pruritic, rash on upper thigh, and arms. Presented to urgent care for steroid admi...
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Erythema, raise, pruritic, rash on upper thigh, and arms. Presented to urgent care for steroid administration.
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| 45 | 2021-01-14 | vaccination site pain |
Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, n...
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Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; This is a spontaneous report from a contactable other health care professional. A 45-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (lot number: EH9899); via an unspecified route of administration on 17Dec2020 14:00 at single dose at arm left; second dose (lot number: EK9231) via an unspecified route of administration on 08Jan2021 00:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic back pain, Allergies to medications, food, or other products: Avocado. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), celecoxib (CELEBREX), pregabalin (LYRICA), triamcinolone acetonide (NASACORT), omeprazole. On 08Jan2021 09:00, the patient experienced Headache, pain at injection site, nasal congestion, nasal pain. The events were assessed as non-serious. There was no treatment received for the events. The outcome of the events was recovering.
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| 45 | 2021-01-14 | vaccination site pain |
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat...
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Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-01-14 | injection site pain, rash |
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati...
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Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
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| 45 | 2021-01-14 | redness, tingling |
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and f...
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Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
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| 45 | 2021-01-14 | vaccination site pain |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
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| 45 | 2021-01-14 | rash papular, itchy rash | Severe pruritic papular rash |
| 45 | 2021-01-15 | injection site pain |
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection...
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Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
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| 45 | 2021-01-16 | injection site swelling |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-16 | sensitive skin, injection site pain |
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivi...
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Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)
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| 45 | 2021-01-17 | tingling |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-17 | rash, hives, itchy skin |
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment...
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Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
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| 45 | 2021-01-19 | hives, tingling, itchy skin |
1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itchin...
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1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itching all through body that comes and goes. Could this be delayed reaction to vaccine? highly concerned about getting 2nd vaccine.
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| 45 | 2021-01-19 | tingling |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | hives | Hives around the waist, weakness/ tired at 0500 1/20 |
| 45 | 2021-01-19 | rash, redness |
I developed a red rash on my torso area that I call a viral rash 48 hours after administration of fi...
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I developed a red rash on my torso area that I call a viral rash 48 hours after administration of first vaccine. The rash was not painful or itchy and resolved within 48 hours.
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| 45 | 2021-01-19 | injection site pain |
Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasti...
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Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasting less than 12 hours.
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| 45 | 2021-01-19 | injection site pain | Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm |
| 45 | 2021-01-19 | rash |
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ...
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Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
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| 45 | 2021-01-19 | tingling |
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are...
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pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
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| 45 | 2021-01-19 | itchy skin |
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine....
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pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
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| 45 | 2021-01-19 | hives, itchy skin |
swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 ...
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swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 swelling of upper lip took Benadryl and it went away on its own a few hours later. Random hives all over body all weekend From 1/15/21 to 1/18/21. Generalized itchy feeling of skin.
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| 45 | 2021-01-20 | itchy skin, hives |
itching and covered in hives/ all over her entire body; itching and covered in hives/ all over her e...
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itching and covered in hives/ all over her entire body; itching and covered in hives/ all over her entire body; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI284), via intramuscular on 07Jan2021 17:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism. Known allergies was none. The patient's concomitant medications were not reported. The patient previously took the first does of BNT162B2 via intramuscular from on 17Dec2020 04:30 PM in right arm at single dose for covid-19 immunization. The patient had no COVID prior vaccination and was not tested COVID post vaccination. No problems at all on day 1 or 2 post injection. On day 3 (10Jan2021 12:00 am), patient woke up in the night itching and covered in hives. not just in her right arm, but all over my entire body. Outcome of events was recovering. The patient took diphenhydramine hydrochloride (BENADRYL) for events.
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| 45 | 2021-01-21 | rash | I had a rash,like small little dots from mid thigh all the way up to my arm pits. |
| 45 | 2021-01-21 | injection site swelling, injection site pain |
severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the le...
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severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the left arm where the injection was received.
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| 45 | 2021-01-24 | redness, skin discolouration, tingling, hives |
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m...
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About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
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| 45 | 2021-01-24 | tingling |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-25 | rash |
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out...
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Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
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| 45 | 2021-01-26 | rash |
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei...
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Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
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| 45 | 2021-01-27 | hives |
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive...
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Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
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| 45 | 2021-01-28 | injection site pain |
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th...
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26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
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| 45 | 2021-01-28 | skin spots, skin discolouration, blister |
petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensatio...
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petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
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| 45 | 2021-01-31 | rash, shingles | Received vaccine on 1/15 and developed rash c/w shingles (herpes Zoster) on 1/28. |
| 45 | 2021-02-07 | injection site pain |
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac...
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Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
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| 45 | 2021-02-09 | rash | tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues |
| 45 | 2021-02-10 | injection site pain |
Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is...
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Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.
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| 45 | 2021-02-14 | tingling |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-16 | vaccination site pain |
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (flutt...
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injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
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| 45 | 2021-02-17 | rash, hives |
First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; U...
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First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-18 | skin discolouration |
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi...
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Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
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| 45 | 2021-02-21 | injection site pain |
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ...
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Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
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| 45 | 2021-02-23 | hives, rash |
dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (bot...
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dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-28 | itchy skin, rash macular |
Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; ...
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Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; Extremely itchy; This is a spontaneous report from a contactable other health professional. A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at 10:30 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included modafinil. On 24Jan2021 at 12:00, the patient experienced diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared. Started next day. So far lasting for 4 days. Extremely itchy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-03-04 | rash, shingles |
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ...
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rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-03-07 | skin discolouration |
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S...
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thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
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| 45 | 2021-03-14 | hives |
Body covered in hives; This is a spontaneous report from a contactable Other-HCP. A 45-years-old non...
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Body covered in hives; This is a spontaneous report from a contactable Other-HCP. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: 3246, dose number:2) via an unspecified route of administration on 03Feb2021 at single dose for Covid-19 immunization. Medical history included hypothyroid, subcutaneous lupus and allergic to sulfa, penicillin, phenergen from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ek9231, dose number:1) via an unspecified route of administration on 12Jan2021 02:30 PM at single dose for Covid-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). On 05Feb2021 at 09:00 AM, the patient's body covered in hives. Then she took oral Benadryl as a treatment. The outcome of event was recovered. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-03-17 | rash |
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health c...
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body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2020-12-31 | redness, rash |
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b...
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Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck Â
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| 46 | 2021-01-02 | hives, rash, itchy skin, rash macular |
4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy h...
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4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy hives on neck, part of face, upper and lower back, a spot on buttock cheek. Also have some itchy spots in under arm area. I took a Loratidine 10mg 24 hour tab to help with itchy hives.
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| 46 | 2021-01-02 | tingling |
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20...
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Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
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| 46 | 2021-01-02 | rash, itchy skin | Rash spreading both arms. Itching all over. |
| 46 | 2021-01-02 | itchy skin, redness |
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs...
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Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
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| 46 | 2021-01-03 | tingling |
After the 15 min monitoring, I went back to work 15 min later. the left side of my face started ting...
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After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.
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| 46 | 2021-01-03 | injection site mass, injection site redness, injection site pain |
On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it...
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On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it started to go away, but never went away completely. It was sore, but not very painful. On day 10, I noticed it was more sore and now there is a lot of redness over injection site. The lump is a little bigger, but not as big as it was originally.
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| 46 | 2021-01-03 | injection site mass, injection site redness, injection site warmth, injection site pain |
Patient states she was advised by nurse that because it was intermuscular (triceps), it may be becau...
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Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021
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| 46 | 2021-01-03 | hives | Throat swelling, urticaria |
| 46 | 2021-01-03 | redness, hives, itchy skin |
Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Your concerns: Vaccine at noon wi...
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Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Your concerns: Vaccine at noon without immediate effect. Driving home at 1400 developed itching and redness at scalp, face, neck, chest, back, arms and sides. Reports that she did not feel warm but looked like she had a sunburn. It appeared to fade over the next two hours but re-occurred at 1700 with all previous symptoms. She took 50mg of Benadryl and went to sleep. She woke at 0200 the re-occurrence of all symptoms, she did not take any Benadryl as that would make her too sleepy to come to work. The symptoms subsided and when we spoke at 1050 she had only small bumps/hive like spots on her fore arms and cleavage. They do not itch or burn at this time. Discussed with PA and Dr. after which I spoke with patient again regarding pending plan. She will call the clinic if she has any further symptomatic episodes in the near future. We will investigate moving her second dose ahead 2 days from 1/12/2021 (day off) to 1/14/2021 this way she will be here at work should it happen again, she works 0630-1900. Med provider will consult with allergy to determine if further steps are needed for dose #2. Dept: Respiratory Therapy Have you missed work? #shifts: none Did you seek emergency care? none Date and Time of Vaccine: 12/22/2020 at 1200 Age at time of vaccination, 46 years 6 months Sex: female Was the vaccine received at facility? yes Site of vaccine (LD or RD): RD Type of Vaccine Pfizer (X ) Moderna ( ) Other _______________ 1st or 2nd dose: first When did your symptoms start? 12/22/2020 at 1400 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain no Tiredness no Headache no Muscle Pain no Chills no Joint Pain no Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell no Swollen Lymph Nodes (lymphadenopathy) no Other: no Employee reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat no A fast heartbeat no A bad rash all over your body yes, see above Dizziness and weakness no If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: see above Plan: see above If employee was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. N/A Employee verbalizes understanding and agreement with plan. yes VAERS report is completed electronically vaccine given at facility. Pending further review. 12/24/2020 01:51pm Follow up to VAER 12/23/2020 Patient called this morning to update regarding vaccine reaction. Yesterday she went home and did some shoveling. Later, around 1900, she developed a itchy, red rash that started on her chest and the right side of her neck which later covered her entire body. The skin on her face was bright red and very hot to the touch, there were small raised hives on her face which were likened to 'petechia if they were raised'. She took pictures of the raised/red areas. She took 50mg of Benadryl and went to sleep, when she woke at 0230 she was asymptomatic. Regarding the bumps on her forearms and cleavage, she has residual mottling on her arms. Updated providers.
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| 46 | 2021-01-03 | redness |
Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. N...
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Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. No issues breathing.
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| 46 | 2021-01-04 | redness |
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of...
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Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
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| 46 | 2021-01-04 | redness |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | redness |
At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an ...
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At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an 800mg and went to bed, woke up the next morning feeling great with no reactions.
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| 46 | 2021-01-04 | injection site pain |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | tingling |
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi...
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Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-04 | rash, itchy rash |
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burni...
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Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
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| 46 | 2021-01-04 | rash, shingles |
I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I start...
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I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.
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| 46 | 2021-01-04 | injection site swelling, injection site redness |
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea...
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Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
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| 46 | 2021-01-04 | hives |
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);...
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Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-04 | vaccination site pain |
severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injec...
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severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
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| 46 | 2021-01-05 | injection site pain, redness |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | injection site pain | Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site |
| 46 | 2021-01-05 | injection site pain, injection site redness, injection site swelling |
Injection site pain, redness at injection site, then followed by chills and fever. Injection site sw...
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Injection site pain, redness at injection site, then followed by chills and fever. Injection site swelling about 2" with fever and redness at injection site - lasted about 5 days. Also was feeling unwell, tiredness & muscle pain for a few days.
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| 46 | 2021-01-05 | tingling | Left arm heaviness with tingling. |
| 46 | 2021-01-05 | injection site redness | RED SQUARE ON ARM AT VACCINATION SITE 2 WEEKS POST IMMUNIZATION. NO TREATMENT . RESOLVED |
| 46 | 2021-01-05 | tingling, itchy skin |
Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/20...
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Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.
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| 46 | 2021-01-05 | rash macular | Red splotches on body - mainly arms |
| 46 | 2021-01-05 | hives, rash | SkinRash, Rash, sevdere fatigue and facial hives |
| 46 | 2021-01-05 | hives, itchy skin |
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ...
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UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
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| 46 | 2021-01-05 | tingling |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-05 | rash |
now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneou...
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now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp). A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination. The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.
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| 46 | 2021-01-05 | tingling |
states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually ...
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states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually resulted in an "ache". No muscle weakness. This has since improved.
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| 46 | 2021-01-06 | injection site pain, injection site swelling |
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj...
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12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
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| 46 | 2021-01-06 | itchy skin |
About two minutes after vaccination the patient began to experience itchiness and throat tightening....
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About two minutes after vaccination the patient began to experience itchiness and throat tightening. Was administered 50 mg capsules Benadryl PO and continued to have worsening symptoms. A physician on site ordered her sent to the Emergency Department for further treatment and observation. She was given famotidine and prednisone and had significant improvement of her symptoms. She was discharged to home
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| 46 | 2021-01-06 | tingling | Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98% |
| 46 | 2021-01-06 | rash macular, redness |
Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; Thi...
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Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
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| 46 | 2021-01-06 | tingling |
Having pins and needles in left hand, today having it in right hand as well, no treatment at this ti...
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Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report
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| 46 | 2021-01-06 | rash |
Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antie...
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Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.
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| 46 | 2021-01-06 | shingles |
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar...
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Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
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| 46 | 2021-01-06 | injection site nodule, injection site swelling | Swollen knot about the size is a silver dollar at the injection site that lasted 3 days |
| 46 | 2021-01-06 | tingling |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | hives |
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he...
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jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-07 | rash |
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa...
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Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
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| 46 | 2021-01-07 | injection site pain | Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain |
| 46 | 2021-01-07 | vaccination site swelling, vaccination site pain |
Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and pain...
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Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.
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| 46 | 2021-01-07 | tingling |
The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pa...
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The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pain. That subsided within a day or two. But I am experiencing numbness and tingling throughout the entire length of my arm. It is not severe and I am still able to conduct my work and daily chores, but it is very concerning to me. It is now 5 days later, and the numbness is not any better. My left pinky finger is the worst out of all of my digits. I'm not sure if they somehow hit a nerve during the injection or if this is a side effect of the shot.
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| 46 | 2021-01-07 | itchy skin |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | hives |
difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in ...
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difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.
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| 46 | 2021-01-07 | hives |
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc...
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she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
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| 46 | 2021-01-08 | swelling |
Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZ...
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Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZER injection. Employee did not experience any SOB or chest pain. ER provider administered steroid injection for treatment. Employee returned to work on the day of discharge and states she will follow up with private allergist for further disposition.
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| 46 | 2021-01-08 | injection site swelling | Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache |
| 46 | 2021-01-08 | injection site pain |
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ...
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Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
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| 46 | 2021-01-09 | tingling |
14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, ...
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14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk
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| 46 | 2021-01-09 | itchy skin, hives | Hives/itching |
| 46 | 2021-01-09 | itchy skin, hives | Itching and hives. |
| 46 | 2021-01-09 | shingles | Shingles |
| 46 | 2021-01-09 | injection site pain | Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day |
| 46 | 2021-01-10 | redness |
Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of brea...
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Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
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| 46 | 2021-01-10 | tingling | Golf ball size lymph node in left axilla, mild tingling in left arm |
| 46 | 2021-01-10 | injection site hardening, injection site swelling, injection site warmth, injection site redness |
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1...
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Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
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| 46 | 2021-01-10 | tingling |
One week after administration, I had sudden onset inability to move left arm. I was transported to E...
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One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.
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| 46 | 2021-01-10 | tingling |
Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on...
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Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on Saturday 1/9 after receiving dose#2 of the Pfizer COVID Vaccine on 1/8 24 hours prior. Her temp went up to 100.4. She took Tylenol and motrin with subsequent resolution of symptoms except some slight body aches and the onset yesterday of bilateral stocking like paresthesia in LE's. As the body aches improved, she noticed the paresthesias more although they have lessened somewhat today. No prior history of COVID. Allgergies: NKA Meds: as above SH: Tob: none. ASSESSMENT Vaccine Reaction to COVID. PLAN Follow up with OMS tomorrow or prn.
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| 46 | 2021-01-10 | rash | Rash and headache |
| 46 | 2021-01-10 | tingling, injection site tingling |
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID...
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The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
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| 46 | 2021-01-11 | tingling |
#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue,...
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#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue, scratchy throat. Over next 2 days pain back of legs, which then evolved into burning and then numbness of palms of hands, soles of feet. Reported to me on 1/8. Over last 3 days, she has had slow improvement with slight tingling and numbness fingers. Over weekend, I had her get tested for COVID - both rapid and PCR neg. She went to ED for testing, and they also ran CT head and labs -- negative. She made appt with neurologist today and will follow up with her PCP. Testing for COVID was to rule out as cause for peripheral neuropathy. Might be due to vaccine vs some other undiagnosed condition including autoimmune. Due to the unique nature of this complaint, may be considered Adverse Reaction
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| 46 | 2021-01-11 | itchy skin, tingling |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | tingling, vaccination site pain |
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is...
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Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
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| 46 | 2021-01-11 | rash, itchy skin | Developed rash with itching and irritation. |
| 46 | 2021-01-11 | injection site pain |
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach...
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Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
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| 46 | 2021-01-11 | injection site pain, injection site numbness |
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e...
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Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
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| 46 | 2021-01-11 | redness |
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai...
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Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
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| 46 | 2021-01-11 | injection site swelling, injection site mass, injection site redness, injection site pain, injection site warmth |
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right...
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Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose. No advert issues or need for medication treatment.
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| 46 | 2021-01-11 | rash | rash and itching around neck and upper chest, tongue feeling funny and tickle in my throat |
| 46 | 2021-01-12 | redness |
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slight...
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01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
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| 46 | 2021-01-12 | injection site pain |
Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis ...
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Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis Around 02:00 am injection site feels sore, chills, Temp 99.9 degrees F, applied warm compress to sore arm 06:00 T=102 degrees, took Tylenol with Benadryl again at 08:30 am, no further fever after, arm still sore but bearable.
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| 46 | 2021-01-12 | cellulitis |
Left elbow cellulitis within 48 hours of vaccine Seen PCP, diagnosed with cellulitis as an adverse ...
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Left elbow cellulitis within 48 hours of vaccine Seen PCP, diagnosed with cellulitis as an adverse reaction to the vaccine and put on antibiotics (Keflex 4Xday for 10 days)
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| 46 | 2021-01-12 | injection site pain | Muscle ache Joint pain Injection site pain Headache |
| 46 | 2021-01-12 | hives, itchy skin |
Patient started itching and had mild hives. Reported to her manager who accompanied her back to the ...
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Patient started itching and had mild hives. Reported to her manager who accompanied her back to the Covid Clinic. Patient was assessed and was given Diphenhydramine 25mg orally x 1.
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| 46 | 2021-01-12 | tingling |
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin...
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Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
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| 46 | 2021-01-12 | injection site numbness | Systemic: numbness at injection site-Severe |
| 46 | 2021-01-13 | tingling |
Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday ar...
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Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.
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| 46 | 2021-01-13 | rash, itchy skin | Exanthema on fingers and lower back w pruritis on all of trunk |
| 46 | 2021-01-13 | rash, itchy skin |
Itchy, rash within 5 minutes of injection - given Pepcid, prednisone, benedryl and also a prescrip...
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Itchy, rash within 5 minutes of injection - given Pepcid, prednisone, benedryl and also a prescription for epipen Took prednisone, benedryl and Pepcid for a few days and notified PCP
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| 46 | 2021-01-13 | rash, hives, itchy skin |
Starting on 1/11/21 she developed a rash over her entire body with some areas of hives. This got wor...
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Starting on 1/11/21 she developed a rash over her entire body with some areas of hives. This got worse the following day. The rash is still present though the itching has improved.
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| 46 | 2021-01-13 | itchy skin, rash |
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ...
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Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
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| 46 | 2021-01-13 | injection site swelling, injection site redness, injection site pruritus, injection site pain |
TWO DAYS OF SINTOMES, PAIN INJECION SITE, HEADACHE, MUSCULAR PAIN, SWELLING IN INJECTION SITE, INCHI...
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TWO DAYS OF SINTOMES, PAIN INJECION SITE, HEADACHE, MUSCULAR PAIN, SWELLING IN INJECTION SITE, INCHING ON INJECTION SITE AND REDNESS.
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| 46 | 2021-01-13 | injection site pain |
fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizzi...
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fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizziness, slight headache and decreased appetite
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| 46 | 2021-01-13 | rash, itchy skin |
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, thr...
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flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, throat itchiness and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
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| 46 | 2021-01-13 | tingling |
paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from ...
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paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date 30Apr2021) via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine (the last dose of Ibuprofen was two or three days ago before 08Jan2021). The patient had received the first single dose of BNT162B2 on 18Dec2020 for COVID-19 immunization and experienced soreness in the left arm which lasted for a day and a half. No other vaccine received within 4 weeks. The patient experienced paresthesia of the left arm and hand on 08Jan2021. She received the first dose of the vaccine on 18Dec2020 in her left arm and had some soreness in the left arm at that time, which was resolved on 20Dec2020 (event reported in AER 2021019477). On 08Jan2021, she received the second dose also in her left arm and within five minutes she had this strange paresthesia of the left arm and hand. She also described it as strange heaviness of the left arm. No limited range of motion of the left arm. She didn't know if it was serious. She didn't visit emergency room or physician office. After two hours (the time of reporting) she still had the same sensation. The event was not resolved. The reporter considered the event paresthesia of the left arm and hand was related to the vaccine.
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| 46 | 2021-01-13 | vaccination site pain |
soreness in the left arm; This is a spontaneous report from a contactable healthcare professional re...
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soreness in the left arm; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date 31Mar2021) via an unspecified route of administration in the left arm on 18Dec2020 right before 9:00 am for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine. No other vaccine received within 4 weeks. The patient experienced soreness in the left arm on 18Dec2020. The event lasted for a day and a half and was resolved on 20Dec2020. The reporter considered the event soreness in the left arm was related to the vaccine.
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| 46 | 2021-01-13 | injection site redness | swelling of arm vaccine administered in, redness at injection site, chills |
| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in all four extremities and st...
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A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
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| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t...
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A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
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| 46 | 2021-01-14 | injection site redness, injection site pain, injection site swelling, injection site warmth |
I have Factor V Leiden, tested positive for Covid on Nov 9, 2020. I received my Covid vaccine on De...
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I have Factor V Leiden, tested positive for Covid on Nov 9, 2020. I received my Covid vaccine on Dec 29, 2020. On Jan 8, 2021 my upper right arm had a red area that was swollen, hot and painful. It continued to spread down my upper are to my forearm. On Jan 12, 2021 I spoke with nurse to see if anyone had reported blood clots as a reaction to the vaccine. Nurse did research this and stated he did not see any cases. After discussion with nurse, we agreed that I would get my PCP to order a venous doppler to rule out clots so we could make an informed decision to receive the 2nd dose vaccine. On Jan 14, 2021 the doppler showed superficial clots.
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| 46 | 2021-01-14 | redness |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-14 | vaccination site swelling, vaccination site redness |
Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneou...
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Redness and swelling on injection site; Redness and swelling on injection site; This is a spontaneous report from a non-contactable nurse (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medication included colecalciferol (VITAMIN D) and Estro-Aid. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscular in the right arm on 17Dec2020 at the age of 46-year-old for COVID-19 immunization and experienced mild cough. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 07Jan2021 20:00, the patient experienced redness and swelling on injection site. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-01-14 | vaccination site pain |
headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); ...
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headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown. Information on batch/lot number was requested.
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| 46 | 2021-01-14 | vaccination site pain |
her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain...
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her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 46 | 2021-01-14 | vaccination site pain, redness, itchy skin, hives |
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i...
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severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
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| 46 | 2021-01-14 | vaccination site pain |
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s...
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sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
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| 46 | 2021-01-15 | skin burning sensation, hives, redness |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-15 | injection site pain | Injection site pain, headache, body aches, joint pain |
| 46 | 2021-01-15 | itchy rash, rash, rash macular |
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ...
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Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
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| 46 | 2021-01-15 | injection site pain, hives, injection site rash |
Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection si...
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Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection site.
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| 46 | 2021-01-16 | injection site pain |
Besides soreness on the injection site on both times, a day after received the second dose of Covid-...
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Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
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| 46 | 2021-01-16 | rash | Generalized rash to be treated with oral steroids and Claritin, outcome not yet known |
| 46 | 2021-01-16 | redness, itchy skin, rash | Itching, small bumps, red face and chest |
| 46 | 2021-01-16 | tingling |
This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was fir...
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This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
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| 46 | 2021-01-17 | tingling |
Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe h...
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Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
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| 46 | 2021-01-19 | redness |
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ...
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A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
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| 46 | 2021-01-19 | itchy skin, hives |
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch...
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About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
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| 46 | 2021-01-19 | tingling |
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai...
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Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
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| 46 | 2021-01-19 | itchy skin |
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl...
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I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
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| 46 | 2021-01-19 | itchy skin, tingling |
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min...
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Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
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| 46 | 2021-01-19 | tingling |
suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; ...
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suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-20 | hives |
Patient developed one singular area of urticaria approximately one hour after the vaccination and th...
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Patient developed one singular area of urticaria approximately one hour after the vaccination and then developed an anaphylactoid reaction 3 days later including widespread urticaria and chest tightness. She took OTC antihistamines and recovered 6 days after the vaccine.
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| 46 | 2021-01-21 | rash |
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe...
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Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
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| 46 | 2021-01-21 | injection site pain | Fatigue; muscle pain at injection site; joint pain; headache; low grade fever; chills. |
| 46 | 2021-01-21 | injection site pain |
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to...
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I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
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| 46 | 2021-01-21 | injection site swelling, injection site redness, injection site pain, injection site warmth |
Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and w...
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Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and warm to touch in 1 and 1/2? diameter circle around injection site. still warm red swollen 3.5 days after injection.
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| 46 | 2021-01-21 | rash |
Patient received the Pfizer Covid Vaccine on 12/31/2020 while she was on day 4 of antibiotics. On 1...
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Patient received the Pfizer Covid Vaccine on 12/31/2020 while she was on day 4 of antibiotics. On 1/6/2021, patient started to have a rash and difficulty breathing. Patient went to ER and was prescribed a different antibiotic. Patient has been on both antibiotics before and has never had a reaction to either. This may be a duplicate report. I did not receive an email confirmation so resubmitting.
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| 46 | 2021-01-21 | hives |
Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Ty...
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Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Tylenol and has finally gone below 100 Hives on chest back behind knees back of legs and bottom of feet. Stated in one spot and progresses thought out the day and night. Took Benadryl and put Benadryl cream on has calmed down after several doses of Benadryl
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| 46 | 2021-01-24 | hives |
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank...
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Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
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| 46 | 2021-01-24 | itchy skin |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | injection site pain |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-25 | injection site pain |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-26 | vaccination site pain |
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; bac...
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Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
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| 46 | 2021-01-26 | sensitive skin, tingling | Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0 |
| 46 | 2021-01-26 | rash | Systemic: Rash (other than injection site)-Severe, Systemic: Headache-Severe |
| 46 | 2021-01-26 | tingling |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-27 | rash |
Exanthema on fingers and back; This is a spontaneous report from a contactable Other Health Professi...
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Exanthema on fingers and back; This is a spontaneous report from a contactable Other Health Professional reported for herself. The 46-year-old female patient that received second dose of bnt162b2 ( COVID 19, Pfizer Biotech, lot number: EL9231), via Intramuscular on 11Jan2021 09:30 AM on Left arm at a single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included Migraine w aura. No allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) Zyrtec, vitamin D and vitamin C. The patient previously took first dose of bnt162b2 (COVID 19, BioNTech/Pfizer, lot number: EL5730) via Intramuscular on 21Dec2020 01:00 PM on Left arm at single dose for covid-19 immunisation. The patient experienced Exanthema on fingers and back from 14Jan2021 06:00 AM. The outcome of the event was recovering. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
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| 46 | 2021-01-28 | rash, rash macular, itchy skin |
itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from up...
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itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); itchy red rash spots on stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 06:30 AM at left arm at single dose for COVID-19 immunization. Medical history included known allergies to milk products and seasonal allergies. Patient is not pregnant. Other medications in two weeks included fexofenadine hydrochloride (ALLEGRA). No other vaccine in four weeks. 8 hours after the first dose of vaccine (15Jan2021 02:30 PM) patient became itchy on upper buttocks and lower back. Then, redness began and now patient have red blotches and a rash from upper buttocks, up her back and on the sides (flanks.) Also, itchy red rash spots on stomach. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Outcome of the events was unknown. Information about lot/batch number has been requested.
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| 46 | 2021-01-28 | tingling |
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ...
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pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
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| 46 | 2021-01-31 | vaccination site pain |
Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactab...
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Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek9213), via an unspecified route of administration at the left arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included diabetes, psoriasis, asthma and Covid (prior vaccination), all from an unknown date and unknown if ongoing. The patient was not pregnant. The patient had no known allergies. The patient's concomitant medications were not reported. On 16Jan2021 07:00, the patient experienced injection site pain, headache, body aches and joint pain. No treatment was received. There was no other vaccine in four weeks. The patient has not had covid tested post vaccination. The outcome of the events was recovering.
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| 46 | 2021-02-03 | tingling, injection site pain |
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te...
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Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
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| 46 | 2021-02-04 | tingling |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-07 | itchy skin | had slight itching to arms; no trouble breathing; no other problems; observed additional 15 minutes; |
| 46 | 2021-02-08 | rash |
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w...
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One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
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| 46 | 2021-02-08 | hives |
headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist...
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headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-02-18 | redness |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-21 | injection site pain, injection site swelling |
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC...
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- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
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| 46 | 2021-02-21 | redness, rash | 40-60 tender red bumps, mostly on torso. |
| 46 | 2021-02-21 | itchy skin |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-22 | injection site redness, injection site numbness |
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight...
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C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
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| 46 | 2021-02-22 | hives |
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho...
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Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
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| 46 | 2021-02-28 | vaccination site pain |
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest an...
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headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
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| 46 | 2021-02-28 | vaccination site pain |
injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of ap...
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injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
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| 46 | 2021-03-01 | hives |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-02 | tingling |
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe...
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migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
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| 46 | 2021-03-04 | vaccination site pain |
body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-conta...
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body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-07 | vaccination site pain |
Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable ...
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Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration in arm on 28Jan2021 10:15 AM at single dose for COVID-19 immunization in workplace clinic. The patient's medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme soreness in the arm that received the shot on 28Jan2021. The event was considered as non-serious by the consumer. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 46 | 2021-03-09 | hives, shingles, itchy skin |
Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shing...
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Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9265), via an unspecified route of administration in left arm on 05Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included Allergic to shellfish, Allergic to soy, Mould allergy, pollen allergies, Atopic dermatitis. There were no concomitant medications. The patient previously took dupilumab (DUPIXENT) from unknown date to 20Dec2020 for Atopic dermatitis. The patient experienced appear to be either shingles or hives, itchy spots on neck face and scalp on 06Feb2021 06:00. Treatment received for the events included Desoxymetasone steroid applied without any effect. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received at the same date of the COVID-19 vaccine. There was no other vaccine received in four weeks. The outcome of the events was not recovered.
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| 46 | 2021-03-09 | rash, hives, redness, tingling |
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything...
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The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
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| 46 | 2021-03-14 | vaccination site pain |
The next day injection site was sore.; This is a spontaneous report from a contactable other healthc...
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The next day injection site was sore.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) Lot number EL9265, via an unspecified route of administration on 31Jan2021 11:30 (at the age of 46 years old) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, montelukast sodium, fluticasone propionate, salmeterol xinafoate (ADVAIR) 500/50. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccination was administered in a hospital. The patient experienced the next day injection site was sore on 01Feb2021. The patient did not receive treatment. Outcome of event was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 46 | 2021-03-15 | itchy skin |
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl...
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First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
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| 47 | 2020-12-31 | hives, rash, itchy skin |
Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with wel...
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Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with welts covering the right side of rib cage and has progressed to covering scalp to ankles.
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| 47 | 2021-01-01 | rash |
Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both ha...
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Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both hands. On 12/26/2020, noticed rash on shoulders and middle back. Noted fatigue and malaise. No fever. On 12/28/2020, rash appeared on upper legs and back of both knees. Noted fatigue and malaise. No fever. On 12/29/2020, rash appeared on both lower legs and on arms. Noted fatigue and malaise. No fever. On 12/30/2020, attempted to make an appointment with primary care provider and was unable to be seen before Jan 6, 2021. On 1/1/2021, went to Urgent Care for evaluation and treatment of full body rash. The only part of my body not affected by the rash is my face. Was prescribed a methylprednisolone dose pack.
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| 47 | 2021-01-01 | itchy skin |
rec'd shot 1405, monitored for 30 min d/t flu vaccine allergy in past as recommended by physician on...
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rec'd shot 1405, monitored for 30 min d/t flu vaccine allergy in past as recommended by physician on call. 35 min in c/o itching to face and neck. monitored for 15 more min, declined cold compress, advised to monitor symptoms
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| 47 | 2021-01-02 | itchy skin |
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST...
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BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
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| 47 | 2021-01-03 | hives, redness | EE presented to EH with c/o hives to face and racing heart rate at 1445 |
| 47 | 2021-01-03 | tingling, injection site pain |
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilate...
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Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
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| 47 | 2021-01-04 | tingling |
At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, f...
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At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)
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| 47 | 2021-01-04 | injection site pain |
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p...
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Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
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| 47 | 2021-01-04 | injection site pain, injection site swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain spe...
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Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain specifically in hands wrists and neck chills muscle pain nausea feeling unwell
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| 47 | 2021-01-04 | tingling, itchy skin |
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. P...
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Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
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| 47 | 2021-01-04 | itchy rash, rash |
Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report f...
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Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on Dec2020 at single dose (dose 1) for Covid-19 vaccination. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID) and vitamin D. The patient experienced rash on her back, it was very itchy on an unspecified date in Dec2020. She reported that she took Benadryl but might not get any relief from it. She had lab work but it was more than 14 days ago, no results reported. The outcome of events not recovered. Information on the Lot/Batch number has been requested.
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| 47 | 2021-01-04 | hives, rash macular | high heart rate, blotchy/flushed skin, urticaria |
| 47 | 2021-01-05 | shingles |
Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved an...
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Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved and currently on second round of anti-virals; delaying second vaccine until shingles resolve
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| 47 | 2021-01-05 | tingling |
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain...
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Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
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| 47 | 2021-01-05 | injection site pain |
Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minut...
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Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minutes after injection. Headache and injection site pain for 2 days after injection.
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| 47 | 2021-01-05 | itchy skin, redness |
Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injec...
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Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injection observation period. Patient was given 25 mg diphenhydramine po, and the symptoms were resolved at 1100. Vitals time 1005 1055 B/P 134/78 130/84 P 65 73 RR 20 16 O2 Sat 98% 99%
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| 47 | 2021-01-05 | tingling |
Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their le...
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Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their left arm and hand. Covid vaccine was given in left deltoid. Patient waited 30 minutes after vaccination with no new symptoms. Patient denies the need for any further medical attention. Patient left with a companion.
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| 47 | 2021-01-05 | tingling |
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous ...
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Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 47 | 2021-01-05 | injection site swelling, injection site pain | soreness and swelling at injection site in small area, chills, and headache. |
| 47 | 2021-01-06 | itchy skin |
About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm ...
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About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm (which was the arm the injection was given in). Patient describes itching as mild. Vitals 1820: BP:129/94 P:83 SaO2: 99% Itching still present but has not worsened or moved to more areas of body. Vitals 1830: BP: 132/88 P: 85 SaO2: 99 Patient states itching has lessened somewhat. Patient denies the need for further care or medication. Patient was able to stand/walk without dizziness and had no other symptoms or complications. After her 30 minute wait time was complete patient left.
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| 47 | 2021-01-06 | hives, redness |
Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive ...
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Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.
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| 47 | 2021-01-06 | itchy skin, hives | Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm |
| 47 | 2021-01-06 | injection site pain |
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work a...
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Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20
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| 47 | 2021-01-06 | hives, itchy skin | Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative: |
| 47 | 2021-01-06 | injection site pain |
Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeli...
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Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeling well
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| 47 | 2021-01-06 | rash, rash papular |
ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED T...
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ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED TO SPREAD ON SIDES OF THE BODY , WAIST AND BUTTOCKS. ON THE 8TH DAY IT CONTINUES TO SPREAD MORE ON GROINS, THIGHS, UPPER BACK AND BILATERAL ARMPIT. BENADRYL TAKEN AND HYDROCORTISONE CREAM APPLIED WITH LITTLE EFFECT, WILL START METHYLPREDNISOLONE TOMORROW
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| 47 | 2021-01-06 | injection site pain, injection site redness, itchy skin |
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ...
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Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
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| 47 | 2021-01-06 | skin discolouration, tingling |
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a...
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Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
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| 47 | 2021-01-06 | rash | SkinRash swelling Narrative: |
| 47 | 2021-01-07 | hives |
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan...
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Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | vaccination site pain, tingling |
Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; modera...
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Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-01-07 | tingling | Pt report bilateral cheek tingling. Treatment include Benadryl, |
| 47 | 2021-01-07 | rash |
Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous repor...
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Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
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| 47 | 2021-01-07 | itchy skin |
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over b...
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Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.
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| 47 | 2021-01-07 | sensitive skin |
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontan...
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Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
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| 47 | 2021-01-07 | vaccination site pain |
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He...
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Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
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| 47 | 2021-01-07 | injection site pain |
Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hou...
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Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.
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| 47 | 2021-01-07 | tingling | Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min |
| 47 | 2021-01-07 | injection site redness, injection site mass, injection site swelling, injection site warmth |
Warm to touch upper left deltoid, large size swollen knot that is red on upper left deltoid, it seem...
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Warm to touch upper left deltoid, large size swollen knot that is red on upper left deltoid, it seems to be getting larger. first noticed on 01/06/21 about 4:30 pm and as of today 1/08/21 the area is still swollen, red and warm to touch.
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| 47 | 2021-01-07 | injection site pain |
When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm...
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When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm pit. Site confirmed by site contact as well. Ice applied
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| 47 | 2021-01-07 | rash, redness |
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r...
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Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
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| 47 | 2021-01-07 | itchy skin, redness |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | tingling |
flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contact...
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flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient). A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation. Medical history included osteoarthritis. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
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| 47 | 2021-01-07 | vaccination site pain, vaccination site swelling, vaccination site itchiness |
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breat...
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noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
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| 47 | 2021-01-07 | injection site redness, injection site pain |
over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tend...
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over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tender skin. Expanded to approximately an area approximately 20 cm in diameter
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| 47 | 2021-01-07 | rash |
rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs...
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rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs and arms; This is a spontaneous report received from a contactable nurse (who is also the patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899), intramuscular in left arm, on 17Dec2020 13:00, at single dose, for COVID-19 immunization. Medical history included ulcerative colitis diagnosed in 2002, and "Allergies to medications, food, or other products: Sulfa medications - cause rash". The patient is not pregnant. Concomitant medication included mesalamine, lithium, lamotrigine and an unspecified birth control pill. It was reported that on 23Dec2020 15:00 (also reported as 17:00, pending clarification), she noticed rash dots on back of both hands. On 26Dec2020 15:00, she noticed rash on shoulders and mid-back. On 28Dec2020 17:00, she noticed rash on upper legs. On 29Dec2020 17:00, she noticed rash on lower legs and arms. On 01Jan2021, she went to urgent care for evaluation and was treated with methylprednisolone dose pack. The patient did not receive any other vaccines with 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. The reporter assessed the report as non-serious.
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| 47 | 2021-01-07 | vaccination site pain, vaccination site swelling |
sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injecti...
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sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | injection site pain |
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is...
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swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-01-08 | injection site pain, itchy skin, rash |
About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke...
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About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke you with body pain everywhere, especially to arm of injection. Running fever of 101.4 and higher, all over body rash that is extremely itchy. Very fatigued feeling.
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| 47 | 2021-01-08 | tingling |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-08 | hives, itchy skin |
Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with B...
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Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin
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| 47 | 2021-01-09 | injection site mass |
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection sit...
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At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
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| 47 | 2021-01-09 | injection site pain | Location site pain X1 day and headache X2 days |
| 47 | 2021-01-09 | itchy skin, redness |
Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requeste...
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Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requested Benadryl. Redness on face and arms. 25 mg's of Benadryl given at 10:28AM. Caregiver discarded to home at 11:15 am.
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| 47 | 2021-01-09 | rash, itchy skin | Severe itching and small rash on legs about 40 hours after the vaccine was given. |
| 47 | 2021-01-10 | rash |
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ...
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3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
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| 47 | 2021-01-10 | injection site tingling, injection site numbness |
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina...
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I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
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| 47 | 2021-01-10 | injection site pain | Mucular pain Achy Joint pain Headache Injection site pain that radiated whole right arm |
| 47 | 2021-01-10 | tingling, injection site pruritus |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | shingles |
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume...
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ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
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| 47 | 2021-01-10 | tingling |
c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips -...
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c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips - per physicians consideration: patient should continue to watch or any signs of swelling, redness, and/or soreness. Tingling/numbness possibly due to hitting a nerve.
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| 47 | 2021-01-11 | rash, hives, redness |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | injection site bruising, injection site redness, injection site hardening, injection site pruritus |
I got the vaccine 12/21/2000. I had some initial hardness at the site. By the next day the harness...
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I got the vaccine 12/21/2000. I had some initial hardness at the site. By the next day the harness was gone and I developed a bruise. I never had any other side effects. On Wednesday 12/30/20 I noticed right under my bruise from the vaccine it became red, slightly itch, and hard.
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| 47 | 2021-01-11 | injection site redness, injection site warmth, injection site pain, injection site swelling |
Initially just had pain at the injection site down my bicep which resolved after 72 hours. On 1/10/...
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Initially just had pain at the injection site down my bicep which resolved after 72 hours. On 1/10/2021 I noticed a very red/warm/swollen area near my injection site.
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| 47 | 2021-01-11 | rash, itchy skin |
Rash and itching to chest, Periorbital and facial edema and rash. Onset aprox 36 hours post vaccinat...
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Rash and itching to chest, Periorbital and facial edema and rash. Onset aprox 36 hours post vaccination of dose 2 Treated with Prednisone 60mg and antihistamines in outpatient setting.
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| 47 | 2021-01-11 | redness |
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (l...
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Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
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| 47 | 2021-01-11 | rash, skin burning sensation, itchy skin |
Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine...
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Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine with complaints of itching, burning feeling on skin and swelling in left arm. Red rash on chest and left arm. No sob, chest pain or difficulty swallowing. Ambulated to emergency room for evaluation.
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| 47 | 2021-01-11 | itchy skin |
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ...
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Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
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| 47 | 2021-01-12 | rash, itchy skin, injection site pain, injection site rash |
I received the vaccine @ 3:26p on 1/7/21 by 9:30p I was dealing with itchiness. I woke up on 1/8 w/s...
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I received the vaccine @ 3:26p on 1/7/21 by 9:30p I was dealing with itchiness. I woke up on 1/8 w/soreness & rash around the injection site & on the left arm. By 6p I had a rash on both arms, back & on my right knee. By midnight I developed a rash on my r foot & belly area. It's 1/13 & I have been taking Benadryl on & off since 1/8 @ 2am. The rash comes and goes on different parts of my body. My physician is now ordering a low dose of prednisone that I will start taking today, 1/13.
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| 47 | 2021-01-12 | tingling | Light fluttery, tingles throughout bilateral arms down through hands- |
| 47 | 2021-01-12 | rash |
Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later exper...
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Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later experienced flushing and redness in chest area and sent to ED for evaluation. Arrived to ED at 9:52 am and was given diphenhydramine 50 mg and famotidine 20 mg. Clonidine 0.3 mg given at 12:18 pm for high BP. At 11:20 am rash almost resolved, feeling better; discharged at 12:30pm
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| 47 | 2021-01-12 | redness |
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving...
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Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
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| 47 | 2021-01-12 | rash | Rash on both forearms and right elbow |
| 47 | 2021-01-12 | injection site pain |
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod...
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Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
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| 47 | 2021-01-12 | tingling |
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down...
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approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
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| 47 | 2021-01-12 | injection site pain, injection site redness, injection site swelling, injection site warmth | nausea, malaise, GI upset, diarrhea; redness, swelling, warmth, pain at injection site |
| 47 | 2021-01-13 | vaccination site pain |
Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dos...
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Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization. The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter. Information about lot/batch number has been requested.
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| 47 | 2021-01-13 | itchy skin | I was a little itchy and took a Benadryl |
| 47 | 2021-01-13 | skin discolouration |
PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING...
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PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING CLEARANCE FROM HER PCP. DUE TO HISTORY OF ANAPHYLAXIS PATIENT MONITORED BY PROVIDER AFTER ADMINSITRATION OF VACCINE. WITHIN 20-30 MINS OF ADMINISTERING VACCINE PATIENT DEVELOPED COUGH AND COLOR CHANGE IN EXTREMETIES. PATIENT TRANSPORTED DOWN TO ED FOR FURTHER EVALUATION.
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| 47 | 2021-01-13 | rash |
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the...
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Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
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| 47 | 2021-01-13 | injection site pain, injection site swelling |
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE...
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THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
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| 47 | 2021-01-13 | skin discolouration, redness, redness |
Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color....
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Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color. Voices s/s of reaction to previous dose (swollen tongue). Initial compliant begin @ 1248, entered observation @ 1242. Benadryl 25mg was given @ 1249. S/S, relieved around 1305. Voices no other s/s of distress. Cold compress also applied to help alleviate s/s. Denies SOB or trouble breathing. Voices allergies to Aspirin, Morphine, Phenergan, Erythromycin. Left observation @ 1310.
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| 47 | 2021-01-13 | rash |
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a...
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a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
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| 47 | 2021-01-13 | itchy skin |
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of...
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intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
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| 47 | 2021-01-14 | rash, pain of skin, shingles |
I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my ...
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I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my PCP and was treated.
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| 47 | 2021-01-14 | itchy skin |
On the 26th I began to have itching all over my body that kept me up at night. I went back to taking...
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On the 26th I began to have itching all over my body that kept me up at night. I went back to taking Claritin and it worked I did get relief when the Claritin wore off I had more intense itching. I tool Claritin around the clock the 24 hours and it stopped after two days. It was a delayed reaction, caught me by surprise. I had no new foods, medications. I did call the after hours Dr to maybe get a steroid injection but he didn't feel it was the best choice and told me to continue the Claritin
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| 47 | 2021-01-14 | injection site redness, injection site rash |
Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Report...
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Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Reports red solid rash in both armpits and a quarter sized red patch at the injection site. Notes One instance of diarrhea.
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| 47 | 2021-01-15 | tingling |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-15 | tingling |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-15 | tingling |
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin...
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Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
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| 47 | 2021-01-16 | injection site pain |
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle...
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Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
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| 47 | 2021-01-16 | hives |
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m...
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I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
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| 47 | 2021-01-16 | rash, shingles |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-19 | injection site warmth, itchy skin, injection site redness, injection site pain, injection site swelling |
At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did no...
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At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did not put the itching together with the injection due to the dry weather. As time went on I noticed the itching mainly on head and upper torso. I had pain by the injection site but lasted only 2 days and was not that bad. The itching improved over the past week but noticed after my second injection that the itching has started back full force. I wake up scratching during the night. The pain in the arm was worse this time and did interrupt my sleep. Today at work I noticed my arm being sore and increased itching and decided to check the site. I found the site to be sightly swollen, red and warm to the touch. Was advised by provider that I work with to take Benadryl which I cannot do at this time until I am off shift as it makes me drowsy.
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| 47 | 2021-01-19 | cellulitis | CELLULITIS 3 DAYS AFTER INJECTION. ANTIBIOTIC |
| 47 | 2021-01-19 | injection site swelling | HEADACHE,CHILLS AND SWELLING INJECTION SITE. |
| 47 | 2021-01-19 | injection site swelling, injection site redness |
Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my...
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Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient). This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks. The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
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| 47 | 2021-01-19 | injection site pruritus |
Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness,...
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Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness, hives or numbness. Rapid Response was called and was advised extra observation time. No other intervention.
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| 47 | 2021-01-19 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my va...
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Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch. As the evening progressed, my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm. This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
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| 47 | 2021-01-19 | hives |
Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to diffic...
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Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to difficulty swallowing. Epi given and pt transferred to ED
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| 47 | 2021-01-19 | injection site pain |
pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours o...
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pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours of vaccine, treated with otc naproxen 220 mg q12 hours prn pain continued next day, continued otc naproxen 220 mg 2 12 hours
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| 47 | 2021-01-21 | injection site pain |
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o...
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Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
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| 47 | 2021-01-24 | vaccination site pain |
2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upp...
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2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
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| 47 | 2021-01-24 | itchy rash |
Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per p...
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Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per patient.
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| 47 | 2021-01-25 | vaccination site redness |
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot...
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High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 47 | 2021-01-25 | rash |
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab...
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Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
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| 47 | 2021-01-26 | injection site pain | chills and fever of 101.4, body aches, sore arm at injection site |
| 47 | 2021-01-31 | rash macular, tingling, rash |
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ...
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my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-01 | injection site tingling, tingling |
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from...
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throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-03 | tingling |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-08 | cellulitis |
Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spont...
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Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-10 | hives |
Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to s...
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Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to stridorous breath sounds.; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, ulcerative colitis, sub clinical Hashimotos, and known allergies to eggs and dairy. Concomitant medication included mesalamine (MESALAMINE), levocetirizine dihydrochloride (XYZAL), budesonide, formoterol fumarate (SYMBICORT), procaterol hydrochloride (PRO-AIR), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 on 31Dec2020 09:30 in left arm(lot number: EL0142) for COVID-19 immunization. The patient experienced hives on face and neck worsening to stridorous breath sounds on 22Jan2021 12:00. The outcome of the events was recovering. The event resulted in an emergency room/department or urgent care. Treatment included Epinephrine, Benadryl, Prednisone. The patient did not have CVOID-prior to vaccination and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported events hives on face and neck worsening to stridorous breath sounds and bnt162b2 cannot be excluded. The patient's underlying risk factors/predisposing condition asthma is considered as a risk factor to develop the event stridorous breath sounds. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 47 | 2021-02-10 | skin burning sensation |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-21 | hives, itchy skin, injection site pruritus, injection site pain, injection site redness |
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an...
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Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
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| 47 | 2021-02-22 | rash, itchy skin |
Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continue...
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Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continued with bumps and itchiness. Went to Urgent Care on February 20th and started steroids. The swelling increases while I am sleeping.
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| 47 | 2021-02-23 | vaccination site redness, vaccination site swelling, vaccination site pain |
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli...
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Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 47 | 2021-03-02 | vaccination site pain |
Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a cont...
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Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 47 | 2021-03-02 | tingling |
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ...
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numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-03-14 | vaccination site pain |
bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous ...
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bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 28Jan2021 13:45 at single dose for COVID-19 immunization in workplace clinic. The patient's medical history included asthma, chronic sinusitis with nasal polyps. The patient have allergies to medications, food, or other products. Concomitant medications included other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient received other medications within 2 weeks of vaccination. It was reported that, woke up the next morning on 29Jan2021 07:00 AM with a bad front of the head headache and injection site was slightly sore when touched. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was not recovered.
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| 48 | 2020-12-31 | injection site pain |
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the...
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After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
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| 48 | 2020-12-31 | redness, itchy skin |
C/O ITCHINESS, NO REDNESS NOTED, 50 MG BENADRYL GIVEN. 154/92, 93, REDNESS TO NECK APPEARING AT 0924...
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C/O ITCHINESS, NO REDNESS NOTED, 50 MG BENADRYL GIVEN. 154/92, 93, REDNESS TO NECK APPEARING AT 0924. 0938 NO NEW S/S, NECK REDNESS REDUCING.
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| 48 | 2020-12-31 | injection site pain | Very sore injection site muscle. Hurt to lay on it. |
| 48 | 2021-01-02 | injection site pruritus, injection site warmth, injection site hardening | 1 week after receiving dose 1 area is hard, warm to touch and itchy |
| 48 | 2021-01-03 | tingling |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | injection site pain, injection site hardening |
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen...
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Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
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| 48 | 2021-01-03 | vaccination site pain |
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula...
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Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
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| 48 | 2021-01-03 | tingling |
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush...
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employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
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| 48 | 2021-01-04 | hives |
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minu...
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30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
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| 48 | 2021-01-04 | redness |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-04 | shingles, rash |
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity...
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I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
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| 48 | 2021-01-04 | injection site nodule, hives, itchy skin, injection site swelling |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | vaccination site pain |
deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of ...
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deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none. The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.
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| 48 | 2021-01-04 | tingling, injection site numbness |
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left s...
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had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
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| 48 | 2021-01-05 | tingling |
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ...
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After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
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| 48 | 2021-01-05 | vaccination site pain |
Arm pain at injection site; general body aches; This is a spontaneous report from a contactable cons...
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Arm pain at injection site; general body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot: EK 5930, intramuscularly on 30Dec2020 11:30 (at the age of 48-years-old), as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin and cephalosporins allergy, possible Behcet's Syndrome, allergies and COVID-19 (diagnosed prior to the vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took codeine and experienced allergies. On 30Dec2020 at 20:00 on the second day (as reported), the patient experienced arm pain at the injection site and general body aches. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the arm pain at the injection site and general body aches was resolving.
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| 48 | 2021-01-05 | tingling |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | injection site pain | Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | injection site pain, injection site pain | Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | vaccination site pain |
Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to ...
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Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), via an unspecified route of administration in left arm, on 30Dec2020 08:15, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications included topiramate and bupropion hydrochloride (WELLBUTRIN). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Most recent COVID-19 vaccine was administered in the hospital. On 30Dec2020 at 4:30 PM, the patient had increased fatigue on the day of vaccination. Also, the patient had a medium to large 3-inch knot to left deltoid with increase soreness and tender to touch. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.
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| 48 | 2021-01-05 | itchy skin | Itching |
| 48 | 2021-01-05 | tingling |
Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for ...
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Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.
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| 48 | 2021-01-05 | tingling |
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit...
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chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
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| 48 | 2021-01-05 | tingling |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-05 | rash |
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. ...
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patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later
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| 48 | 2021-01-06 | rash |
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minu...
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Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
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| 48 | 2021-01-06 | injection site pain | Headache, soreness at injection site, extreme muscle aches and fatigue lasting from 12/25 to 12/30. |
| 48 | 2021-01-06 | rash, rash papular |
I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination ...
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I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.
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| 48 | 2021-01-06 | injection site pruritus |
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie...
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Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
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| 48 | 2021-01-06 | redness |
NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having...
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NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.
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| 48 | 2021-01-06 | hives, tingling |
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a...
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On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
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| 48 | 2021-01-06 | rash |
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking...
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Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
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| 48 | 2021-01-06 | injection site pain |
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/heada...
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Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
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| 48 | 2021-01-07 | tingling |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | hives, injection site pain, itchy skin |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-07 | vaccination site pain |
Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoul...
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Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; This is a spontaneous report from a contactable nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 03Dec2020 at 16:00, at a single dose, for COVID-19 immunization. Medical history included hypertension (HTN). The patient has no known allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. On 04Dec2020, at 05:00 a.m., the patient initially experienced soreness at the injection site. Over the next 4 days (today is day 4), patient experienced pain in left shoulder, back, and up the back of head/neck which was getting progressively worse - now excruciating. Ibuprofen managed the pain for the first two days, but the soreness/pain was no longer managed with NSAID's and other comfort measures. Patient was hoping that these are normal and was hoping they will get better. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 48 | 2021-01-07 | injection site pain |
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuf...
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Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling "foggy".
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| 48 | 2021-01-07 | rash | Shortness of breath, cough, rash on face and neck, arthralgia |
| 48 | 2021-01-07 | redness |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-08 | rash macular |
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest an...
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Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
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| 48 | 2021-01-08 | rash | Elevated Heart rate and blood pressure. Blotching to chest and neck. difficulty swallowing. |
| 48 | 2021-01-08 | tingling |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-08 | redness |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-09 | injection site pain |
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l...
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1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
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| 48 | 2021-01-09 | sensitive skin, tingling |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-10 | injection site pain, redness |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | itchy rash | Itchy rash like break out on left side lower back |
| 48 | 2021-01-10 | injection site redness, injection site swelling | Low grade fever 100.5, headache, severe body aches, redness and swelling at the site of injection. |
| 48 | 2021-01-10 | injection site pain | Patient experienced low grade fever, chills, headache and soreness at injection site. |
| 48 | 2021-01-10 | injection site pain, pain of skin |
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and...
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Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
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| 48 | 2021-01-11 | rash |
I am having bad rash all over; I started getting in middle in my back and now it just everywhere; Th...
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I am having bad rash all over; I started getting in middle in my back and now it just everywhere; This is a spontaneous report from a contactable consumer reporting for herself. A 48-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the right arm on 03Jan2021 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced bad rash all over; she started getting in middle in her back and now it just everywhere on 03Jan2021 shortly after vaccination with outcome of unknown. The patient was doing anti-histamine and hydrocortisone cream as treatment. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-11 | injection site pain | L axillary lymph node swelling and pain ( shot was in L deltoid injection site_) |
| 48 | 2021-01-11 | itchy skin |
Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administratio...
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Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administration. She was given Benadryl, Pepcid, Solumedrol with symptom relief. She did not require epinephrine.
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| 48 | 2021-01-11 | redness |
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s...
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Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
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| 48 | 2021-01-11 | itchy skin, hives |
itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a c...
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itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, from 02Jan2021 16:45 to 02Jan2021 16:45 at 0.3 mL, single for covid-19 immunization. Medical history reported as "none". There were no concomitant medications. The patient noticed hives on the back of her legs this morning 05Jan2021. She has taken oral Benadryl which took all the itching and irritation away but the hives are still there. Further described as "they are welty feeling and looking". She added that she was not scheduled for the second injection yet, they told her to wait for an email to arrive for her to set it up. She has informed her primary HCP of her hives. Outcome of events itching and irritation was recovered whereas the patient had not recovered from hives at the time of this report.
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| 48 | 2021-01-12 | hives |
(1035 VAC. ADMINISTERED); 1415- RETURNED TO VACC. CENTER- C/O RT ARM VAC. SITE REACTION OF HIVES. E...
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(1035 VAC. ADMINISTERED); 1415- RETURNED TO VACC. CENTER- C/O RT ARM VAC. SITE REACTION OF HIVES. EMS ON SCENE. VS: 98.5 F, 02 SAT: 96% R.A.; P: 74; BP: 159/85; 1422: NO C/O. VSS. 1426: LEFT AND WENT TO ER.
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| 48 | 2021-01-12 | tingling |
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa...
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11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
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| 48 | 2021-01-12 | injection site pain |
Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right a...
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Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right arm pain where I received the injection. That evening/night the symptoms progressed to headache and severe chills through the night.
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| 48 | 2021-01-12 | shingles | Developed Shingles rash on 1/23/2020 |
| 48 | 2021-01-12 | injection site pain | Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla |
| 48 | 2021-01-12 | injection site pruritus |
Patient complained of itchy feeling to the left deltoid area of injection site. Patient took band-ai...
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Patient complained of itchy feeling to the left deltoid area of injection site. Patient took band-aid off and stated she has a history of itching with adhesives prior. Alert and oriented x3. Respirations easy and unlabored. Skin pink warm and dry. Denies any SOB, feeling of doom, etc. Sipped on H2O without difficulty swallowing. Upon inspection of injection site, no swelling, rash, hives, etc. Denies N/V.
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| 48 | 2021-01-12 | injection site pruritus |
Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy an...
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Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any distress/discomfort. At 1640, patient complained of itching at injection site. Patient stated she has a history of developing itchy feeling due to adhesive from bandages. Patient removed the bandage. RN administering IM injection inspected site: no swelling, rash, hives, or other s/s of inflammation. Patient still alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any feeling of doom, nausea, vomiting, shortness of breath, elevated heart rate, etc. RN administering injection gave patient an ice pack to apply to left upper arm. Monitoring patient. Patient sitting in chair in vaccine clinic waiting room area. Sipping on H2O due to complaint of feeling thirsty. No difficulty swallowing water. EMS called to Vaccine Clinic for unrelated issue. Once EMS on scene, patient further evaluated by EMS (Biox 98%). Patient asking to be transported to ER. EMS taking patient per patient request.
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| 48 | 2021-01-12 | itchy skin |
Some itching during stay started 10 minutes after observation period started. kept 45 min. improved ...
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Some itching during stay started 10 minutes after observation period started. kept 45 min. improved after went home. Declined need for ED visit.
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| 48 | 2021-01-12 | tingling |
Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, ...
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Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, then spread to right arm. Described sensation as 'what it feels like when you sleep on your arm funny'.-Mild
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| 48 | 2021-01-13 | vaccination site pain |
Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise ...
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Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.
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| 48 | 2021-01-13 | tingling |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | tingling |
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi...
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Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
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| 48 | 2021-01-13 | injection site pain |
H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underar...
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H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underarm area of affected side. Symptoms have lasted from about 10 hours after the dose and are continuing now (82 hours after the dose)
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| 48 | 2021-01-13 | rash |
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at...
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Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
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| 48 | 2021-01-13 | rash | Patchy red rash extending to forearm |
| 48 | 2021-01-13 | redness |
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu...
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Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
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| 48 | 2021-01-13 | tingling | Reported heart rate of 108, a week of paresthesias. Symptoms resolved |
| 48 | 2021-01-13 | shingles |
Shingles outbreak 5 days after vaccination; This is a spontaneous report from a contactable other he...
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Shingles outbreak 5 days after vaccination; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscular on 22Dec2020 at single dose on the right arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient experienced shingles outbreak 5 days after vaccination on 27Dec2020. The event was assessed as non-serious. Acyclovir pills were given as treatment. Since the vaccination, the patient has not been tested for COVID-19. It was also reported that "Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit". Outcome of the event was not recovered.
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| 48 | 2021-01-13 | injection site pain |
got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painfu...
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got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painful, headache and body ache. Took a day off today.
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| 48 | 2021-01-13 | injection site pain | headache, tiredness, extreme pain at injection site |
| 48 | 2021-01-13 | redness |
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ...
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knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
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| 48 | 2021-01-13 | tingling |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-14 | tingling |
At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting abou...
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At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting about 1 sec each time.
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| 48 | 2021-01-14 | injection site pain | Extreme fatigue, strong headache, pain on injection site, muscle pain all over the body |
| 48 | 2021-01-14 | hives |
Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). ...
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Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
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| 48 | 2021-01-14 | redness |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | redness, rash, itchy skin, injection site redness, hives |
Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She...
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Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020. Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
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| 48 | 2021-01-14 | sensitive skin |
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday...
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Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
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| 48 | 2021-01-14 | rash, itchy skin | Slight rash, itchy all over |
| 48 | 2021-01-14 | tingling | Sévère arthralgia, not able to walk. Facial paresthésie. Extreme fatigue, chills and fever |
| 48 | 2021-01-14 | tingling |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-14 | injection site swelling, injection site pruritus, injection site pain, injection site redness |
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then...
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Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
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| 48 | 2021-01-14 | redness |
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w...
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day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
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| 48 | 2021-01-14 | itchy skin |
itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days...
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itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on 23Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. Medical history included dry eyes, carcinoma in situ, and procedure of complete hysterectomy. The patient was not pregnant at the time of vaccination. Concomitant medications included camellia sinensis extract (GREEN TEA), ciclosporin (RESTASIS), estradiol (VIVELLE DOT). The patient previously took augmentin and experienced allergies. The patient experienced itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days on 23Dec2020 09:30 and was treated with cetirizine hydrochloride (ZYRTEC) x1 on the second day. The patient recovered from the event on 25Dec2020.
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| 48 | 2021-01-14 | tingling |
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness...
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severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
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| 48 | 2021-01-15 | rash, shingles |
1/8 back pain, 1/9 lesion L flank, 1/11 Md prescribed acyclovir for shingles, 1/13 rash progress tow...
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1/8 back pain, 1/9 lesion L flank, 1/11 Md prescribed acyclovir for shingles, 1/13 rash progress toward spine, 1/15 spots under navel L side, blood test comes back negative for shingles On 1/7 son dx covid
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| 48 | 2021-01-15 | tingling |
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res...
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L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
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| 48 | 2021-01-16 | injection site pain |
@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced head...
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@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced headache and took ibuprofen and headache resolved about 1 hour later @2130 on 1/16/21 began to experience chills and general malaise and another headache, took ibuprofen. @0130 on 1/17/21 woke up sweating, with a headache, continued malaise, and chills, took ibuprofen @0730 on 1/17/21 woke up with headache, took ibuprofen @1300 on 1/17/21 fatigue, chills and malaise returned. Still present at time of this submission. Rest and ibuprofen have provided minimal relief.
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| 48 | 2021-01-16 | vaccination site pain |
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat...
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A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
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| 48 | 2021-01-16 | tingling | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-17 | tingling |
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard....
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At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
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| 48 | 2021-01-17 | injection site pain | Chills, muscle pain, tiredness, injection site pain, feeling malaise |
| 48 | 2021-01-17 | injection site pain, injection site redness |
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4...
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Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
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| 48 | 2021-01-17 | tingling, rash, itchy skin |
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la...
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I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
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| 48 | 2021-01-17 | redness, itchy skin |
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an...
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On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
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| 48 | 2021-01-17 | tingling |
tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on ...
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tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination. On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events "tingling sensation in right eye and mid cheek area" and "muscles on the right side of her face were noticeably weaker" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-19 | injection site pain |
Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to...
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Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
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| 48 | 2021-01-19 | itchy skin |
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl...
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Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
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| 48 | 2021-01-19 | injection site pain | Fever, body aches, nausea, vomiting, injection site pain |
| 48 | 2021-01-19 | itchy skin, rash |
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, ...
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HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
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| 48 | 2021-01-19 | vaccination site pain |
Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contact...
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Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
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| 48 | 2021-01-19 | rash, injection site pruritus |
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than inj...
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Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
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| 48 | 2021-01-19 | rash | body rash, lip swelling and tingling |
| 48 | 2021-01-19 | vaccination site pain |
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node...
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injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
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| 48 | 2021-01-21 | redness |
Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). ...
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Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). She was being monitored and within 15 minutes her upper lip was swelling. She also had redness on her face. Oxygen levels were stable. Blood pressure monitored and was high (200s/ low 100s). Gave patient 2 tablets of Benadryl. Patient had no throat swelling or trouble breathing. She was taken to the local ER. At the ER, the patient was given steroids. She was release from the ER within a few hours. She is currently at home and is stable.
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| 48 | 2021-01-23 | redness |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | injection site swelling |
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe...
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23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
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| 48 | 2021-01-24 | injection site pain |
Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at...
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Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at injection site.
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| 48 | 2021-01-24 | injection site pain |
Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vacc...
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Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vaccine.
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| 48 | 2021-01-24 | hives, rash, itchy skin | ITCH, RASH, THEN HIVES TREATED WITH epi |
| 48 | 2021-01-24 | tingling |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-25 | rash | Chills, rash, sore throat, low grade fever starting one week after the vaccine |
| 48 | 2021-01-25 | vaccination site pain |
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report...
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Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | tingling, itchy skin |
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a con...
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Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | redness |
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan...
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Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
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| 48 | 2021-01-25 | itchy skin |
Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same d...
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Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same day recipient was seen in the ED with itchiness and dry heaves. Was treated with steroids, Benadryl, and Pepcid. On 1/17/2021 recipient returned to the ED with complaints of shortness of breath and itchy throat; she was unable to take oral steroids
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| 48 | 2021-01-25 | injection site pain | Sore Injection Site, Neck Pain, Nausea and Weakness |
| 48 | 2021-01-26 | rash |
Developed rash on neck, superior to clavicles bilaterally. Treating with Triamcinolone 0.025% cream...
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Developed rash on neck, superior to clavicles bilaterally. Treating with Triamcinolone 0.025% cream topically
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| 48 | 2021-01-26 | injection site swelling, injection site redness, injection site pain |
My right shoulder had intense deep muscle and surface soreness around the injection site that kept ...
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My right shoulder had intense deep muscle and surface soreness around the injection site that kept me awake the first night of receiving the first vaccination. The site was slightly swollen and warm to the touch with a few red dots that did not itch. I did use 500mg of Tylonal to help alleviate the pain. Within 35 hours of the first injection, my arm was not as tender or sore to the touch and did not keep me awake at night. Although still sore, 48 hours later, there is no more swelling and the redness and red spots are gone.
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| 48 | 2021-01-26 | hives | Sore Arm, Fatigue, General feeling of sick, Hives, |
| 48 | 2021-01-26 | rash, itchy skin, injection site swelling |
Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness lik...
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Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness like golf ball size at and around site the next morning. Still itching the next morning after taking Benadryl and Tylenol every 4 hours as suggested by physician.
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| 48 | 2021-01-26 | vaccination site swelling |
swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling s...
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swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
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| 48 | 2021-01-27 | tingling |
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weaknes...
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severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma. There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
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| 48 | 2021-01-28 | tingling |
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin...
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Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 48 | 2021-02-03 | rash |
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid...
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Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
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| 48 | 2021-02-08 | injection site swelling |
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t...
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Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-16 | skin spots |
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ...
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Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
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| 48 | 2021-02-21 | injection site pain, rash, injection site swelling, injection site redness |
Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after s...
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Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after shot)... started to ice arm an hour after appointment and continued to ice throughout the day Friday. Saturday morning the injection side was significantly swollen (bump and felt like a knot) and continues to be swollen and ache as of Monday a.m. Have a red circular patch around injection site which also occurred after first shot and lasted 10 days. Saturday woke up with bad headache... took tylenol and slept.. headache gone by late afternoon. Sunday morning woke up covered in a rash that was from my neck to below my belly button on front side, entire back area (including neck) and both sides of torso. Took 2 doses of Benadryl on Sunday. Rash has faded (not as red) and took another dose of Benadryl Monday morning.
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| 48 | 2021-02-21 | injection site swelling, injection site hardening |
I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Har...
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I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.
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| 48 | 2021-02-21 | rash, itchy skin |
On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip. I applied...
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On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip. I applied lotion and when I got home from work at 7 p.m., the rash was more painful and prominent. I took Benadryl and applied Cortizone cream. This morning when I woke up, the rash was still there. All day I have periodically applied Cortizone cream to keep the itching and slight pain at bay. The rash consists of small red bumps over a 3 inch by 3 inch area.
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| 48 | 2021-02-21 | redness |
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende...
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arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-02-22 | tingling | Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash. |
| 48 | 2021-02-22 | redness |
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa...
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Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
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| 48 | 2021-02-22 | rash | transient rash to bilateral legs |
| 48 | 2021-02-23 | rash |
breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactabl...
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breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.
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| 48 | 2021-02-25 | rash, vaccination site pain |
chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axilla...
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chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.
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| 48 | 2021-03-02 | hives |
Hives; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female...
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Hives; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 28Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma and postpartum cardiomyopathy on unknown dates and unknown if ongoing. The patient had allergies to sulfa and penicillin. Prior to vaccination, the patient has not had COVID-19. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), carvedilol (manufacturer unknown), cefixime (FLEXERIL), losartan (manufacturer unknown) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Cipro, Biaxin and Ampicillin and allergies. Since the vaccination, the patient has not been tested for COVID. The patient experienced hives on 30Jan2021. The patient did not receive any treatment for the event. The patient has not recovered from the event. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-03-02 | tingling |
mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; Th...
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mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on the left arm, on 31Jan2021 13:30, at single dose, for covid-19 immunization. Medical history included penicillin allergy. Concomitant medications included temazepam; spironolactone and; silybum marianum (MILK THISTLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received the vaccine in the hospital. It was reported that shortly after the vaccination, on 31Jan2021 the patient experienced mild tinging in her left arm that went away; but when she woke-up she noticed tingling in her feet and they also feel cold on 31Jan2021. The outcome of the event mild tingling in her left arm was recovered on 31Jan2021. The outcome of the events tingling in her feet and they also feel cold was unknown. The patient has not been COVID-tested post-vaccination.
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| 48 | 2021-03-14 | tingling |
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore...
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pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
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| 48 | 2021-03-28 | injection site numbness, injection site tingling | Left arm is numb and tingles running from site of injection down to my wrist |
| 49 | 2020-12-31 | injection site pain |
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1...
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mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
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| 49 | 2021-01-01 | itchy skin, redness |
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ...
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12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
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| 49 | 2021-01-03 | rash |
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute...
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10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
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| 49 | 2021-01-03 | pain of skin, injection site redness, injection site swelling |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | injection site pain |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-03 | itchy skin, redness |
I had itching and redness and knots that formed in my left leg. The knots were at the site of a ver...
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I had itching and redness and knots that formed in my left leg. The knots were at the site of a vericose vein. I sought tx at an ER on 12/26 to ensure it was not a blod clot. I followed up with my family dr on 1/4/2021 (When her office reopend) and was diagnosed with Superficial Thrombophlebitis. The knots remain in my leg. The redness has mostly gone away. My PCP felt as I recenlty had covid, the vaccine likely flared up the inflamation in my body and caused this condition.
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| 49 | 2021-01-03 | vaccination site swelling, injection site redness |
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ...
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I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
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| 49 | 2021-01-03 | redness, rash, itchy skin | Itching, rash and redness through out body. |
| 49 | 2021-01-03 | tingling, itchy rash, rash papular, rash |
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ...
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Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
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| 49 | 2021-01-03 | injection site pain, injection site redness, injection site swelling |
Started with pain at injection site the day after vaccine was given. The following day (2 days afte...
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Started with pain at injection site the day after vaccine was given. The following day (2 days after vaccine), there was a quarter size bump and it was tender when touched. At one week, the site was no longer tender but still erythema surrounding injection site, slightly larger. At 2 weeks, noticed bump was more diffuse had spread (~4-5 cm) with more noticeable erythema around the edges. Contacted employee health at this time who advised me to contact my PCP and submit VAERS report. No fever or other systemic reactions during this period. Unsure if 2nd vaccine should be given.
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| 49 | 2021-01-03 | tingling |
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou...
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Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
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| 49 | 2021-01-03 | injection site pain |
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim...
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pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
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| 49 | 2021-01-04 | injection site redness, injection site swelling | 9 days later had large red mark raised and bump at vaccine site. |
| 49 | 2021-01-04 | injection site nodule, injection site warmth, injection site redness |
I developed a small knot at the injection site the day after i received it. By the following evening...
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I developed a small knot at the injection site the day after i received it. By the following evening it had grown to the size of a baseball. It was red, warm, indurated and it itched. Though when I attempted to scratch it was very painful. I took Benadryl on the evening January 2nd and have taken cetirizine for the past two days. It has gotten slightly smaller and the itching has improved though not completely resolved.
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| 49 | 2021-01-04 | injection site pain, tingling |
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af...
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I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
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| 49 | 2021-01-04 | rash, itchy rash | Itchy rash developed on extremities and buttocks. |
| 49 | 2021-01-04 | injection site pain |
Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is...
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Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting
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| 49 | 2021-01-04 | injection site pain, injection site swelling, pain of skin |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | redness |
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an...
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swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
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| 49 | 2021-01-04 | vaccination site pain |
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ...
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throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
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| 49 | 2021-01-04 | hives, vaccination site warmth, vaccination site swelling, injection site redness | welts around body, buttocks, arm, legs. vaccine site redness, puffiness, warm to touch |
| 49 | 2021-01-05 | injection site pain, tingling, skin burning sensation, injection site redness |
After receiving the injection in the right arm, the patient began to feel pain and burning at the in...
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After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.
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| 49 | 2021-01-05 | injection site bruising, injection site redness, bruising |
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha...
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Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
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| 49 | 2021-01-05 | vaccination site pain |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | hives | Headache for 4 days following vaccine. On day 5 following vaccine developed hives on arms and chest. |
| 49 | 2021-01-05 | itchy skin, hives |
Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching...
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Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching, severe feet itching; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 22Dec2020 16:00 at single dose at left arm for COVID-19 immunization. Medical history included allergies Ct contrast. The patient's concomitant medications were not reported. ON 23Dec2020 04:00, 12 hours post injection- the patient experienced Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk. 24 hours after the first incident, the patient experienced severe palm itching, another 24 hours later, the patient then experienced severe feet itching. The AE resulted in emergency room/department care. The patient received treatment for the events (Solumedrol). The events was assessed as non-serious. The outcome of the events was recovering.
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| 49 | 2021-01-05 | injection site reaction |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | itchy skin, tingling, hives |
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to...
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UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
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| 49 | 2021-01-05 | hives, rash, itchy skin |
coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and...
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coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.
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| 49 | 2021-01-06 | rash papular | 9 x 5 cm area of raised redness and pain left arm starting on on day 8 |
| 49 | 2021-01-06 | injection site hardening, injection site pruritus, injection site redness |
?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 1...
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?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm. Pfizer vaccine Lot EL0142. 0.3ml IM, left deltoid. states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21. Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve. PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness. A picture of the affected area is available if requested
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| 49 | 2021-01-06 | injection site pain |
About an hour after the injection I had pain and burning going down my left side and in the left sid...
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About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
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| 49 | 2021-01-06 | hives, injection site hardening |
DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECT...
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DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECTION SITE GOT HARD. LAST A FEW HOURS AND THEN HIVES WENT AWAY. NO MEDICINE WAS TAKEN TO HELP RESOLVE.
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| 49 | 2021-01-06 | injection site pain, tingling |
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g...
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Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
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| 49 | 2021-01-06 | hives |
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm...
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Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
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| 49 | 2021-01-06 | bruising |
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4...
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Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.
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| 49 | 2021-01-06 | tingling |
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ...
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Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
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| 49 | 2021-01-06 | tingling |
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos...
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Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
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| 49 | 2021-01-06 | tingling |
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l...
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Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
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| 49 | 2021-01-06 | tingling |
Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient ...
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Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.
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| 49 | 2021-01-06 | rash |
SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes aro...
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SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes around neck. BP 132/80, P 96, R 18, O2 sat 100%, T 98.6 Given Cetirizine 10 mg po and observed for 30 minutes. @ 1405 BP 123/65, P 65, R 18. Resolved and d/c'd at 1410. Updated in employee record on database
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| 49 | 2021-01-06 | injection site pruritus, injection site redness, rash, hives |
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i...
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Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
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| 49 | 2021-01-06 | redness |
cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her l...
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cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her lt axilla
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| 49 | 2021-01-06 | tingling |
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al...
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felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
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| 49 | 2021-01-07 | injection site pain |
1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience q...
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1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time. Also experience shortness of breath.
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| 49 | 2021-01-07 | vaccination site pain |
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver...
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100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
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| 49 | 2021-01-07 | injection site pain, injection site swelling |
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ...
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12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
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| 49 | 2021-01-07 | redness, itchy skin | Caregiver complained of a "heavy" throat and had redness and itching to her neck and chest area |
| 49 | 2021-01-07 | redness, rash |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | tingling |
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the...
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Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
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| 49 | 2021-01-07 | injection site pain |
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea S...
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Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later
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| 49 | 2021-01-07 | injection site pain, injection site inflammation |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | tingling |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | injection site pruritus, itchy skin |
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove...
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Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
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| 49 | 2021-01-07 | injection site pain | Pain at site, shooting down the arm and unable to lift arm. Shoulder frozen. |
| 49 | 2021-01-07 | tingling |
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1...
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Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
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| 49 | 2021-01-07 | rash papular, itchy rash |
Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They re...
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Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They red bumps and itches; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (arm left) on 28Dec2020 12:00 at single dose (dose 1) for COVID-19 immunization. Medical history included psoriasis from an unknown date and allergies to medications, food, or other products (unspecified). The patient was taking unspecified concomitant medications including a vaccine within 2 weeks. Patient did not receive other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknown results. On 29Dec2020 04:00, the patient had some skin rashes as a reaction when there is an allergen. After the vaccines, she has been having occasional rashes that pops at different places. They were red bumps and itches. She stated she needed to keep antihistamines CLARITIN/BENADRYL on the clock. Event outcome was not recovered. The patient underwent lab tests and procedures which included COVID test (Nasal swab): negative on 24Nov2020. Event outcome was not recovered. Patient considered the events as non-serious.
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| 49 | 2021-01-07 | hives |
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc...
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Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
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| 49 | 2021-01-07 | itchy skin, hives | UrticariaPruritus |
| 49 | 2021-01-07 | tingling |
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1...
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developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
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| 49 | 2021-01-08 | swelling | Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins |
| 49 | 2021-01-08 | injection site warmth | Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating |
| 49 | 2021-01-08 | hives, itchy skin | UrticariaPruritus, Diarrhea & NauseaVomiting |
| 49 | 2021-01-08 | itchy skin |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-09 | injection site mass, injection site swelling, injection site redness, injection site pain |
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had...
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Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
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| 49 | 2021-01-10 | injection site pain, injection site warmth |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-10 | itchy rash, rash |
EE sts COVID 19 vaccine #2 taken 1/9/21 approx. 2 hour later developed a red itchy rash to L foot fr...
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EE sts COVID 19 vaccine #2 taken 1/9/21 approx. 2 hour later developed a red itchy rash to L foot from toes to mid calf, R foot only to ankle, B/L ears and B/L dorsal hands. EE sts took 50 mg Benadryl and Melatonin and went to sleep. EE sts at appx 9pm took Benadryl 25 mg for itching. EE sts symptoms resolved and have not returned since 10pm 1-10-21
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| 49 | 2021-01-10 | injection site pain | Pfizer-BioNTech COVID-19 Vaccine EUA headache injection site pain general malaise |
| 49 | 2021-01-10 | injection site redness, injection site hardening, injection site warmth |
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti...
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Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
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| 49 | 2021-01-10 | rash, itchy rash |
Stating many details to help determine whether or not this is not vaccine related: onset of red and ...
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Stating many details to help determine whether or not this is not vaccine related: onset of red and blistery rash, similar to a contact dermatitis with no known new contact substances; rash started on upper front torso, spread to folds under breasts and downward to abdomen and around to lower back; over several days spread to upper arms, elbow pits and below; next to shoulder areas and knee pits; 01/11/2021 the rash is still spreading slowly, itchy and inflamed, while parts of the original rash have begun to scab and heal. Due to holidays and level of inflammation and blistering, cosmetic surgeon recommended and PCP called-in 7-day round of Keflex to curb possible infection in breast creases beginning 12/26/2020. Taltz dose dates were 12/11/2020 and 01/08/2021. Breast augmentation 11/13/2020 (no adverse reaction to surgical tape, stitches or staples in this or prior procedures).
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| 49 | 2021-01-10 | rash, itchy skin |
Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and...
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Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and follow up with PCP.
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| 49 | 2021-01-11 | hives | Hives started within 24 hours and have been ongoing for two weeks |
| 49 | 2021-01-11 | injection site swelling, injection site redness, injection site pain |
Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen ...
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Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen and red and sore (mild)
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| 49 | 2021-01-11 | redness |
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau...
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painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
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| 49 | 2021-01-11 | itchy skin, rash | rash and diffuse itching |
| 49 | 2021-01-12 | tingling |
Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provi...
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Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provider onsite: NP evaluated the client, advised to wait for another 15 minutes. @0932 per client she is feeling better. Provider onsite advised client to see her PMD if the reaction will get worse. Client left the clinic in Ambulatory stable condition.
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| 49 | 2021-01-12 | hives, rash | Dizzy, light headed, hives on left side of neck and chest. |
| 49 | 2021-01-12 | injection site pain, injection site swelling | Injection site raised and sore Sore throat |
| 49 | 2021-01-12 | injection site pain |
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels ...
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Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
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| 49 | 2021-01-12 | injection site pain |
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to...
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chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
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| 49 | 2021-01-12 | injection site pain |
vaccine in am. That night had back pain. left hip pain and when walking felt like dragging left leg....
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vaccine in am. That night had back pain. left hip pain and when walking felt like dragging left leg. Ice to injection site due to discomfort also.
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| 49 | 2021-01-13 | itchy skin |
15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was admin...
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15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was administered diphenhydramine 25mg orally and observed . No additional side effects occurred
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| 49 | 2021-01-13 | injection site nodule, injection site pruritus, injection site warmth, injection site redness |
Developed itchiness, redness, and hard spot that was warm to touch at injection site and below as we...
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Developed itchiness, redness, and hard spot that was warm to touch at injection site and below as well as muscle pain in the arm as if she had been punched in the arm, first instance of this began over 1 week after injection. Seen in convenient care clinic and prescribed 7 day course of doxycyline for concern of possible abscess.
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| 49 | 2021-01-13 | injection site pain |
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p...
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Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
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| 49 | 2021-01-13 | itchy rash, rash |
Patient developed rash approximately 24 hours after receiving the vaccine. Rash was on chest, face,...
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Patient developed rash approximately 24 hours after receiving the vaccine. Rash was on chest, face, and back. Lasted for about a week, but has improved. Itched the whole time.
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| 49 | 2021-01-13 | injection site numbness |
Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with t...
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Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
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| 49 | 2021-01-13 | injection site numbness |
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other sympto...
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c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
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| 49 | 2021-01-13 | vaccination site pain, vaccination site itchiness, vaccination site redness |
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery...
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felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
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| 49 | 2021-01-13 | itchy skin, hives | hives from neck to thighs, itchy, aches all over |
| 49 | 2021-01-14 | injection site pain |
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches...
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1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
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| 49 | 2021-01-14 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s...
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After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
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| 49 | 2021-01-14 | injection site pain, redness, injection site pruritus |
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i...
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Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
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| 49 | 2021-01-14 | injection site pain |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | hives | Fever >101, nausea, urticaria. Treated for urticaria with steroids, H2 and H1 blockers |
| 49 | 2021-01-14 | vaccination site pain |
Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old...
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Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 40113/ej1686), via an unspecified route of administration (anatomical location: left arm) from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE for an COVID-19 immunisation. Medical history included diabetes, asthma and overweight. The patient's concomitant medications were not reported. On 04Jan2021, the patient experienced soreness at injection sight. Outcome of the event was unknown.
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| 49 | 2021-01-14 | vaccination site itchiness |
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face...
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the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
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| 49 | 2021-01-15 | injection site redness, injection site pain, injection site warmth, injection site swelling |
Red arm, swollen, warm covered entire arm from shoulder to elbow itching and pain went away in about...
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Red arm, swollen, warm covered entire arm from shoulder to elbow itching and pain went away in about 4 days
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| 49 | 2021-01-16 | injection site pain |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-17 | tingling |
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ...
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49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
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| 49 | 2021-01-17 | rash, redness |
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ...
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palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-17 | redness |
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t...
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swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
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| 49 | 2021-01-19 | tingling |
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my...
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29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
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| 49 | 2021-01-19 | hardening |
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ...
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: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
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| 49 | 2021-01-19 | injection site swelling |
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil...
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Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
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| 49 | 2021-01-19 | injection site pain |
Patient reports acute pain at the injection site immediately after vaccination that lasted for an ho...
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Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck. The pain is somewhat relieved by NSAIDs.
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| 49 | 2021-01-19 | redness, tingling, rash macular |
Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been go...
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Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been going on about 10 mins before she said anything. Benadryl 25mg given @ 1705. Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine. Remains to voice s/s @ 1729. Red Blotchy areas noted to face and neck. Pt states this is normal for her when her anixety level is high. V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm. V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%. States that takes BP meds daily @ night, in which she hasn't taken her meds all day. Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg. Stil continues to voice s/s @ 1739. BP remains elevated. Patient sent to ER @ 1740. Pt entered registration @ ER @ 1745. Pt continue to voice s/s of prickling noted to body. Denies SOB nor trouble w/ breathing.
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| 49 | 2021-01-19 | injection site pain | chills, low-grade fever (99.6 F), injection site pain |
| 49 | 2021-01-19 | tingling |
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens...
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generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
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| 49 | 2021-01-20 | tingling |
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches...
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fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-21 | injection site pain | CHILLS, BODY ACHE. INJECTION SITE SORENESS. |
| 49 | 2021-01-21 | injection site swelling, injection site redness | Fever, chills, muscle and joint aches. Redness and large lump with swelling at injection site. |
| 49 | 2021-01-24 | redness |
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ...
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I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
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| 49 | 2021-01-24 | rash |
Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out ...
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Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out in pimples; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EH9899) in the left arm, on 22Dec2020 at 09:00, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypothyroidism. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN). On 24Dec2020, the patient experienced rash on face that looked like she broke out in pimples. No treatment was received. The patient recovered from the adverse event on an unspecified date. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.
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| 49 | 2021-01-25 | vaccination site pain |
Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous repor...
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Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-01-25 | vaccination site pain |
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con...
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migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
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| 49 | 2021-01-26 | rash | RASH ON THE SKIN, DIARRHEA |
| 49 | 2021-01-28 | injection site pain |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-02-01 | injection site nodule, injection site pain, pain of skin |
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ...
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a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
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| 49 | 2021-02-16 | hives, itchy skin |
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac...
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Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-21 | tingling |
RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WI...
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RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WITH COMPLAINT OF LEFT ARM PAIN (TINGLING, HEAVY SENSATION). DIAGNOSED WITH PARESTHESIA OF LEFT UPPER EXTREMITY, GOITER, AND DEGENERATIVE DISC DISEASE. DISCHARGED TO HOME SELF CARE.
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| 49 | 2021-02-22 | redness, injection site discomfort |
Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood i...
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Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood in the country. COVID vaccine injection site is about two inches away from the smallpox scar.
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| 49 | 2021-02-22 | hives |
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;...
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hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-23 | injection site warmth, injection site redness, injection site pain | redness warmth & soreness to injection site |
| 49 | 2021-02-28 | vaccination site warmth |
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil...
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2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 49 | 2021-02-28 | vaccination site pain |
arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself)...
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arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via intramuscular route of administration in the left arm on 29Dec2020 at a single dose because "a coworker came down with Covid." Medical history included migraine and headache. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient reported that her arm hurt with first dose on an unspecified date. There were no relevant tests conducted. The outcome of the event was recovering.
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| 49 | 2021-03-04 | vaccination site swelling, tingling |
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ...
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She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
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| 49 | 2021-03-07 | injection site pain |
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a...
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Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
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| 49 | 2021-03-08 | tingling, skin discolouration |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | vaccination site pain, vaccination site warmth |
right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult...
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right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.
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| 49 | 2021-03-12 | blister, sensitive skin, redness, tingling |
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist...
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Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
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| 49 | 2021-03-15 | rash, itchy skin, skin discolouration, redness |
I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got...
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I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got itchy all over my body, my face turned red and with many outbreaks, I went back to clinic and the doctor gave me an injection, I got better a little but it gave me a lot of hyperactivity, when I arrived at home I couldn't handle the itch in the body and I felt my throat closing my husband took me to emergency, I couldn't breathe well, and I was itchy from head to toe. I stayed in emergency and I got some green discoloration very big on my legs, I have to go to the allergist because I still had itchy in the body
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| 49 | 2021-04-08 | bruising, rash, itchy skin |
After 1st shot (Feb 11) - 5 days after, I started vomitting and running a fever for 2 days, my stoma...
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After 1st shot (Feb 11) - 5 days after, I started vomitting and running a fever for 2 days, my stomach was upset until the second shot After 2nd shot (March 4) - 2 days post shot, I started excessive itching - after 11 days, and trying various antihistamines - the bruising and rashing from itching covered my entire body. I started jaundice on March 17, this continued to worsen and is still present.
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| 50 | 2020-12-31 | injection site pain |
Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injec...
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Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injection site, headache, tiredness day after vaccination. Took Motrin 600 mg which relieve headache.
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| 50 | 2020-12-31 | rash, itchy skin, hives |
I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was...
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I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away. The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.
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| 50 | 2021-01-03 | itchy skin |
35 minutes after administration of vaccine, patient started to experience itching on the right palm ...
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35 minutes after administration of vaccine, patient started to experience itching on the right palm and shortly after the left palm which was resolved by taking 25 mg of benadryl
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| 50 | 2021-01-03 | skin discolouration, rash |
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e...
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After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
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| 50 | 2021-01-03 | itchy skin |
Approximately 35 minutes after administration of vaccine, patient experienced itching on right palm ...
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Approximately 35 minutes after administration of vaccine, patient experienced itching on right palm then after a while to the left palm which resolved by taking 25 mg Benadryl
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| 50 | 2021-01-03 | injection site pain | Constant and severe Pain from injection site traveling all the way up my arm and into my neck. |
| 50 | 2021-01-03 | hives |
Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexameth...
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Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexamethasone 10mg IM for treatment and diphenhydramine PO 25 mg. Symptoms subsequently resolved.
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| 50 | 2021-01-03 | hives, itchy skin |
dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. ...
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dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. Vitals monitored, were normal, sent home and advised to take Benadryl. More hives on upper lip/chin appeared 36 hours after vaccine given. Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
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| 50 | 2021-01-04 | bruising |
2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral c...
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2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral calf, left lower leg in the medial aspect, right tibial tubercle area, left medial knee, right distal forearm, left wrist underneath her watch, posterior olecranon processes, posterior proximal humerus bilaterally. No bruises in the trunk, back, face or neck. She started Plavix treatment with Cardiologist 12/28/20. Cardiologist, Hospital physician.approved her to get the COVID vaccine. She will call her Cardiologist and let us know what course of action resulted. She could just be bruising from mild trauma that she is unaware of since Plavix is a new med for her. States she does cross her legs when she sits and leans on her elbows. Shoulder bruising seems to be where she lays when in bed.
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| 50 | 2021-01-04 | itchy skin |
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro...
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8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
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| 50 | 2021-01-04 | vaccination site pain |
Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that...
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Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that the COVID vaccine was given; It was hard to lift her arm and woke her up when she was sleeping; It was hard to lift her arm and woke her up when she was sleeping; This is a spontaneous report from a contactable consumer (patient, occupation: Respiratory Therapist). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 11:00 (reported as Approximately 11am in the morning) at single dose to help stop the spread of COVID. Location of the COVID Vaccine: Right arm. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no prior Vaccinations with 4 weeks. Medical history included she had tested positive for COVID on 02Oct2020. The patient did not have any illness at time of vaccination. Family Medical History Relevant to adverse event also reported as none. There were no concomitant medications. The patient previously had flu vaccine given at the hospital she works at and She had mild arm soreness after the Flu vaccine. The patient experienced Right arm soreness in the same arm that the COVID vaccine was given on 22Dec2020, Chills on 23Dec2020, Muscle ache on 23Dec2020, Headache on 23Dec2020, did not feel well in general on 23Dec2020. Caller reported that she experienced right arm soreness, in the arm she received the vaccine, that was unlike any other vaccine she had ever had. The arm soreness began the same evening as the day she received the COVID vaccine. It was hard to lift her arm and woke her up when she was sleeping in Dec2020. The remainder of the side effects began the following morning after she had received the COVID Vaccine. Other side effects included chills, which lasted until the 24th or 25Dec2020. Muscle aches, which lasted until the 24th or 25th Dec2020. Headaches, which she is still getting off and on, but it is hard to say if the headaches that she is still getting is still from the COVID vaccine. The headaches are coming less often. She has had to take something for the headaches. Caller stated that she did not feel well, in general. Asked caller what other vaccines she had received and had experienced arm soreness but not to the extent she had after the COVID Vaccine and caller stated that she had mild arm soreness after the Flu vaccine. Previous flu vaccines had been given to her at the hospital she works at; therefore, she did not have any lot number information for these flu vaccines. The reported adverse events did not require a visit to Emergency Room and Physician's office. The patient was not hospitalized. The outcome of event Right arm soreness in the same arm that the COVID vaccine was given was recovered on 26Dec2020, the outcome of the event Chills, Muscle ache was recovered in Dec2020, the outcome of the event did not feel well in general was recovered on 25Dec2020. The outcome of the event Headache was recovering. The outcome of the other events was unknown. The causality assessment for events Right arm soreness in the same arm that the COVID vaccine was given, Chills, Muscle ache, Headache, did not feel well in general with suspect COVID vaccine was assessed as related by Primary Source Reporter via Method of assessment Global Introspection. Information on the lot/batch number has been requested.
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| 50 | 2021-01-04 | rash | Red face rash morning of 2 days following vaccine Dull headache, day of vaccine |
| 50 | 2021-01-04 | rash |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | rash |
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex...
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body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
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| 50 | 2021-01-04 | rash, redness |
day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days ...
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day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
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| 50 | 2021-01-04 | bruising |
fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report...
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fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Other products, patient history and investigation assessment was No. There were no concomitant medications.She provided her weight as 140, 142, or 143 lbs. After administration of the COVID 19 vaccine there was a fair amount of bleeding after the needle was removed. It could have been the administration process. Another resident here had the same experience, but she was unsure if the resident received the Pfizer of Moderna vaccine. This was day 5 and the caller still had a bruise. The current caller said she developed a good size bruise, and she didn't bruise easily. She didn't have a prescribing doctor. She got it at the city hospital, where she worked. She was not on anticoagulants. She had not taken aspirin or Motrin. The outcome of the event bruise was not recovered, of other event was unknown.
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| 50 | 2021-01-04 | itchy skin, hives |
hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a head...
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hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.
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| 50 | 2021-01-05 | pain of skin |
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the...
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. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
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| 50 | 2021-01-05 | itchy skin, rash, hives |
Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a t...
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Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
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| 50 | 2021-01-05 | tingling |
Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/20...
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Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/2020. Employee states she cannot turn key in door or use right arm and hand normally. Employee reports parasthesias including slight numbness and tingling. Employee reports pain that is in the back of her shoulder that is rated as 2-3/10. Employee states all of her symptoms have been the same since 12/30 and have not worsened and no new symptoms had started.
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| 50 | 2021-01-05 | hives, injection site redness, injection site warmth, injection site reaction, injection site pain, injection site pruritus |
Had welt at injection site the size of golf ball with redness spreading from site out about the size...
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Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.
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| 50 | 2021-01-05 | tingling | Pfizer-BioNTech COVID-19 Vaccine EUA left arm and leg persistent paresthesias for two weeks |
| 50 | 2021-01-05 | tingling |
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ...
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Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
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| 50 | 2021-01-05 | injection site swelling, injection site redness, injection site pruritus |
The evening of the vaccine around the injection site exp redness, swelling lasted 3 days went away....
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The evening of the vaccine around the injection site exp redness, swelling lasted 3 days went away. After 10 days the injection site it appeared 3 inches was deep, red and exp itching. I took Benadryl the redness, swelling went away.
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| 50 | 2021-01-05 | injection site pain, tingling |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-06 | injection site pain, injection site swelling |
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin...
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Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
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| 50 | 2021-01-06 | injection site swelling, injection site pain |
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A...
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MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
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| 50 | 2021-01-06 | tingling |
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ...
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Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
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| 50 | 2021-01-06 | skin burning sensation, tingling, redness |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | tingling | tinnitus, face tingling, lymph pain, general muscle pain |
| 50 | 2021-01-07 | injection site pain |
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty...
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01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
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| 50 | 2021-01-07 | rash macular |
20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/...
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20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.
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| 50 | 2021-01-07 | hives, itchy skin | Anaphylaxis with a hives, itching, and airway involvement |
| 50 | 2021-01-07 | tingling |
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body...
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Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
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| 50 | 2021-01-07 | itchy skin |
Mild itching that started within 20 minutes of injection that I thought was a result of my sweater m...
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Mild itching that started within 20 minutes of injection that I thought was a result of my sweater material. But itching increased over a couple hours of time even after changing clothes. No rash on body. Just itching all over. Benadryl helped calm itching and it finally started subsiding around 4 hours later.
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| 50 | 2021-01-07 | redness, injection site hives |
Patient had local reaction. Hives at site, redness on neck and face. Benadryl 25mg given po. Pati...
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Patient had local reaction. Hives at site, redness on neck and face. Benadryl 25mg given po. Patient monitored about30 minutes.
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| 50 | 2021-01-07 | rash |
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o...
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approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
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| 50 | 2021-01-07 | tingling |
decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain s...
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decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20. No weakness, back pain or injury.
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| 50 | 2021-01-07 | hives, itchy skin |
dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives ...
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dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 50 | 2021-01-07 | injection site pain | inject site soreness, dizziness, headache, chills |
| 50 | 2021-01-07 | hives, itchy skin | itching, welp |
| 50 | 2021-01-07 | tingling, itchy skin |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-08 | pain of skin |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | injection site pain |
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B...
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About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
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| 50 | 2021-01-08 | injection site pain, injection site swelling |
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a...
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Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
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| 50 | 2021-01-08 | rash, shingles |
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subseq...
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Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
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| 50 | 2021-01-08 | tingling |
Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever...
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Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue
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| 50 | 2021-01-08 | injection site pain |
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot ...
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Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)
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| 50 | 2021-01-08 | tingling | Tingling and a feeling of numbness to R side of face |
| 50 | 2021-01-08 | hives, itchy skin | UrticariaPruritus Narrative: 12/19-12/21 hives to R wrist, chest, back, neck |
| 50 | 2021-01-09 | injection site pain |
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start...
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Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
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| 50 | 2021-01-09 | hardening | Low grade fever, large hard painful lump in right arm, achy joints |
| 50 | 2021-01-09 | rash |
swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 5...
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swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 50 mg of benadryl at 815, at 830 I took zyrtec 10 mg and went to the ER. At 945 they gave me a shot of decahedron and discharged me at 10 30 with prescription for oral steroids, epi pen and instructions to take pepcid, zyrtec twice daily and benadryl as needed.
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| 50 | 2021-01-10 | injection site pain |
Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain...
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Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain in the site of injection making arm unable to rise more than 30 degrees from 11:00am day of vaccination until 12/20/2020
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| 50 | 2021-01-10 | injection site pain |
Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body...
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Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021
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| 50 | 2021-01-10 | injection site swelling, cellulitis, injection site redness, injection site hardening |
Later same night 1/8//21 my arm was red swollen with hard lump at injection site. Not sure if injec...
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Later same night 1/8//21 my arm was red swollen with hard lump at injection site. Not sure if injection might have been given subcutaneous instead of intramuscular. The redness and swelling has increased each day. Have been marking borders abs each morning the redness has expanded and is bigger. It does not hurt or itch. The lump is not as hard but can still feel hard area surrounding injection site. clinic called in antibiotics to treat cellulitis.
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| 50 | 2021-01-10 | bruising |
While getting ready for work after showering on 1/11/2021 before 0630 this morning, I noticed a pre...
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While getting ready for work after showering on 1/11/2021 before 0630 this morning, I noticed a pretty large bruise on the inner left thigh of my left leg. I was shocked to see it. This bruise wasn't present prior to the vaccination. I also didn't injure my leg which would've caused the bruise. It isn't painful, but surprised to see it there. I'm sure the bruise will heal in a few days. I took a photograph if it and will monitor it.
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| 50 | 2021-01-11 | hives, itchy skin | 1/11/21 developed itching and hives to ears, neck, chest, trunk and arms. |
| 50 | 2021-01-11 | tingling |
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig...
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30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
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| 50 | 2021-01-11 | injection site pain |
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU...
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GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
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| 50 | 2021-01-11 | injection site pain |
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR...
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INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
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| 50 | 2021-01-11 | injection site reaction | INJECTION SITE, HEADACHE TIRED, CHILLS,FEVER,NAUSES,MODERATE COUGH |
| 50 | 2021-01-11 | rash, itchy skin, hives, redness | On 1/11/21 developed itching, redness, hives to ears, neck, chest, trunk and arms. |
| 50 | 2021-01-11 | injection site pain |
Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to ...
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Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to rise, all night fever as high as 104.2 despite multiple doses of Tylenol, chills, severe headaches
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| 50 | 2021-01-11 | tingling |
Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of rece...
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Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of receiving the COVID vaccine. Fifty mg of liquid diphenhydramine was administered & the patient was monitored for another 45 minutes. She reported her symptoms slowly improved over time. No throat or tongue swelling was reported at any time.
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| 50 | 2021-01-11 | injection site warmth, injection site redness, injection site pain, injection site swelling |
Post vaccination, HCW reports she sustained Right arm swelling, pain, warmness to touch. Red spots...
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Post vaccination, HCW reports she sustained Right arm swelling, pain, warmness to touch. Red spots were noted at injection site and was warm to touch. HCW reported staggering Motrin 800mg and Tylenol 1000mg around the clock for a period of 3 days. Also used cold compress to to right arm. On 01/12/2021, 5 days post vaccination, HCW reports some relief in pain , decrease in arm swelling and improvement in redness at the injection site. The HCW sought evaluation at the facility's Occupational Health Center and was instructed to continue Motrin and cold compress and report back if symptoms worsens.
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| 50 | 2021-01-11 | rash, hives |
Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol,...
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Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol, and albuterol
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| 50 | 2021-01-11 | injection site redness, injection site pain |
Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started f...
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Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started feeling like I'm going to have an asthma attack." She reported having headache, chills, her heart racing, "I feel like my airway is closing that I had to cough". Vital signs were taken by staff at the clinic. Patient reported BP was elevated, HR elevated, but O2 Sat was 100%. Within 15 mins symptoms resolved. Patient returned to her work area in the ED that same morning. During her shift she took Motrin for a headache. On 1/8/21, @ 2330 started feeling burning sensation on the injection site, noticed that there was a blister and redness on the area. . 1/11/2021, she reported redness at the injection. All other symptoms resolved on its own.
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| 50 | 2021-01-11 | vaccination site pain |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-11 | tingling |
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensif...
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Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
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| 50 | 2021-01-11 | vaccination site pain, redness |
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ...
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both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
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| 50 | 2021-01-11 | rash, injection site pain, rash macular |
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod...
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day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
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| 50 | 2021-01-12 | hives, rash | Hives diffusely involving arm back eye and chin. No anaphylaxis. |
| 50 | 2021-01-12 | itchy skin, hives | Hives/itching - Benadryl taken and is being taken every 4-6 hrs |
| 50 | 2021-01-12 | itchy skin | Itching- mild different areas Palms of hands |
| 50 | 2021-01-12 | injection site pain | Lt arm injection site soreness, body malaise, low grade temp, chills, fatigue |
| 50 | 2021-01-12 | injection site pain | Pain at injection site, extreme fatigue, general body ache, temperature 102 F |
| 50 | 2021-01-12 | tingling |
Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm sh...
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Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm shoulders pain body aches and fever
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| 50 | 2021-01-12 | rash | Systemic: Rash (other than injection site)-Medium |
| 50 | 2021-01-12 | hives, vaccination site itchiness, itchy skin |
Vaccine received at 10:10. Mild pruritus occurred at vaccination site at 10:25. Quickly progressed t...
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Vaccine received at 10:10. Mild pruritus occurred at vaccination site at 10:25. Quickly progressed to upper body widespread hives and itching/ Received 0.3mg epi in Right thigh at 10:35 and 25 mg Benadryl. All hives resolved by 10:40 and itching resolved by 11:00
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| 50 | 2021-01-13 | redness |
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar...
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"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
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| 50 | 2021-01-13 | itchy skin |
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte...
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Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
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| 50 | 2021-01-14 | injection site pain, injection site nodule |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | itchy skin |
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient beg...
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Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
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| 50 | 2021-01-14 | tingling |
HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED...
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HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED LEFT SIDE OF THE FACE, NUMBNESS LIKE I WAS GIVEN LOCAL TO THE LEFT SIDE OF MY FACE. COULD BARELY FEEL MY FACE ONLY LEFT SIDE. FELT I WAS DROOPING. TEETH WAS TINGLING. MY LEFT ARM GOT BETTER IN 2 HOURS. THERE WAS NO WEAKNESS. HOWEVER MY LEFT SIDE OF THE FACE WAS NUMB AND TINGLING LASTED APPROXIMATELY 2 DAYS. INTENSITY OF THE NUMBNESS GOT BETTER BY THE EVENING OF THE SHOT. I TOOK 325 MG OF ASPIRIN WITHIN 15 MIN OF THE EPISODE . MY PULSE, BP AND OTHER VITALS NORMAL. MAIN WAS MY LEFT SIDE OF THE FACE .
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| 50 | 2021-01-14 | tingling |
I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring ...
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I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring fingers. I Thought that I had slept in my hand wrong.; The discomfort at injection site woke me again last night and had the same feeling. It has remained after waking this morning; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 7530) solution for injection, via an unspecified route of administration on right arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies to food, medications, or other products. The patient was not pregnant. Patient had the first dose of BNT162B2 on 18Dec2020 (lot number: EK 7530). Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), and melatonin at 1.5 mg, daily. The patient reported that on 09Jan2021, she woke about 3 am and had paresthesia of her fingers on her right hand, thumb, index, middle and ring fingers. She thought that she had slept in her hand wrong. The discomfort at injection site woke her again last night (09Jan2021) and had the same feeling. It has remained after waking this morning. No treatment was given. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.
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| 50 | 2021-01-14 | itchy skin |
Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling wors...
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Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling worsening over the 5 days after injection leading to Urgent Care visit.
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| 50 | 2021-01-14 | injection site pain |
Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered ...
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Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered inhaler
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| 50 | 2021-01-14 | tingling |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | injection site redness, injection site pain, injection site pruritus |
old scar that I forgot that I have there, it just swelled up really bad; The injection site looked l...
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old scar that I forgot that I have there, it just swelled up really bad; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; Injection site began to itch; Injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142 (also reported as EL0140, pending clarification), expiry date: 03Mar2021 (also reported as 31Mar2021, pending clarification), intramuscular on the right arm on 08Jan2021 06:30 at a single dose for covid-19 immunisation. Medical history included heartburn, hot flashes, Grave's disease (father also has Grave's disease), had a thyroidectomy in Dec2015, menopause, weight loss, and appetite control, allergies, compromised immune status (brother and father side with autoimmune), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, and diabetes type 2 diagnosed in 2019 (both parents and brother also with diabetes). Concomitant medications included levothyroxine sodium (SYNTHROID) in Dec2015 for Grave's disease and had a thyroidectomy, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) on 02Jan2021 for heartburn, phentermine for weight loss and appetite control, estradiol on 02Jan2021 for hot flashes and menopause, medroxyprogesterone acetate (PROVERA) on 02Jan2021 for hot flashes and menopause, prednisone for unexplained whelps (pending clarification), and cimicifuga racemosa (also reported as black cohosh) for hot flashes. The patient previously took metformin and experienced GI upset (she quit taking metformin/it was causing GI upset because they increased dose/current dose is 1,000mg twice daily increased from 500 mg twice daily) and generic levothyroxine sodium and experienced feels like crap. The patient had no previous history of immunization with the Pfizer vaccine. No additional vaccines administered on same date of the bnt162b2. No prior vaccinations within four weeks. The patient wanted to know if she can receive the second dose of the Covid vaccine after experiencing adverse events. On 08Jan2021, the patient experienced some injection site soreness, in which she took TYLENOL for. Around 14:30, she noticed that the injection site began to itch. Around 16:00, the injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle. The patient also reported, "scar that I have on my arm, it is not a reaction, it is an old scar that I forgot that I have there, it just swelled up really bad." Event injection site looked like a smallpox vaccine was assessed as serious-other medically important condition. No emergency room or physician's office required. Therapeutic measure was taken as a result of injection site soreness. Outcome of the event injection site looked like a smallpox vaccine was not recovered. Outcome of the events injection site soreness, injection site began to itch, vaccination site erythema, vaccination site scab, vaccination site discoloration, and old scar that I forgot that I have there, it just swelled up really bad was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event vaccination site discomfort cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-15 | hives, itchy skin | Body aches for 24 hours. Itching and welts in areas 42 hours after injection. |
| 50 | 2021-01-15 | injection site mass | Fever, chills, vomiting, cough, diarrhea, painful lump at injection site, fatigue |
| 50 | 2021-01-15 | injection site pain | Sore deltoid lasting approximately 12 hours. |
| 50 | 2021-01-15 | injection site pain, injection site swelling |
nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme...
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nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme exhaustion. I had to leave work early and take the next day off. I slept 14 hours on that day off.
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| 50 | 2021-01-16 | injection site pain, rash papular, injection site redness |
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102...
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At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s. I had redness from above the injection site down to my elbow x 4 days. The area was raised 1/2 inch. I had to take Benadryl to help with the reaction. On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast. Had a severe headache x 4 days with neck stiffness. The swelling in my axilla improved by 1/15/21. The redness and swelling in the arm resolved by 1/15/21. Headache still lingered till 1/16/21. Was out of work x 4 days
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| 50 | 2021-01-16 | itchy skin, injection site pain |
itchy toes both feet similar to symptoms experienced with possible covid infection in past sore arm...
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itchy toes both feet similar to symptoms experienced with possible covid infection in past sore arm at injection site no treatment
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| 50 | 2021-01-17 | tingling, vaccination site pain |
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I fe...
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I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
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| 50 | 2021-01-19 | redness, hives |
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell...
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Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
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| 50 | 2021-01-19 | injection site pain | Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site |
| 50 | 2021-01-19 | injection site swelling, injection site pain, injection site reaction | Swelling, deep muscle ache/spasm at injection site. Tylenol taken and ice pack at site |
| 50 | 2021-01-21 | injection site pain |
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu...
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Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
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| 50 | 2021-01-21 | rash |
I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or f...
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I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or five days.
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| 50 | 2021-01-21 | skin burning sensation |
Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shi...
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Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shifts.
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| 50 | 2021-01-21 | tingling |
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu...
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Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
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| 50 | 2021-01-24 | tingling |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-24 | hives |
HIVE LIKE RASH SPREADING FROM LOWER EXTREAMITYS TO HEAD AND NECK, ON GOING FOR A MONTH SEFT TREAT W...
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HIVE LIKE RASH SPREADING FROM LOWER EXTREAMITYS TO HEAD AND NECK, ON GOING FOR A MONTH SEFT TREAT WITH ANTIHISTAMINE WITH SOME IMPROVEMENT. SCHEDULED FOR DERMATOLOGIST VIIST
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| 50 | 2021-01-24 | redness, itchy skin |
Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arm...
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Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arms and torso.; This is a spontaneous report from a contactable Other HCP (patient). A 50-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 09:00 at SINGLE DOSE at Left arm for COVID-19 vaccination. The patient was not pregnant. Medical history included hypertension. Concomitant medication in two weeks included omeprazole (PRILOSEC [OMEPRAZOLE]), doxycycline and otc vitamins. The patient previously took oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET) and experienced drug allergies. On 12Jan2021 10:00, the patient experienced itching and redness on head, itching on arms and torso. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-01-25 | tingling |
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef...
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About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
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| 50 | 2021-01-25 | tingling |
Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tin...
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Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tingling in arm". After waiting approximately 30 minutes after first report of tingling, patient stated tingling resolved with no other signs/symptoms.
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| 50 | 2021-01-25 | itchy skin |
Itching all over; This is a spontaneous report from a contactable nurse (reported for herself). A 50...
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Itching all over; This is a spontaneous report from a contactable nurse (reported for herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246; expiry date: not known), via an unspecified route of administration in the left arm on 11Jan2021 11:00 at single dose for COVID-19 immunization, administered in hospital. There was no medical history. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced itching all over on 15Jan2021 08:00. The reported event is considered non-serious. Therapeutic measures were taken as a result of itching all over with diphenhydramine. The outcome of the event was unknown.
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| 50 | 2021-01-26 | pain of skin |
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa...
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Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
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| 50 | 2021-01-26 | itchy skin |
Patient returned to the vaccine clinic a couple of hours after receiving vaccine with complaints of ...
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Patient returned to the vaccine clinic a couple of hours after receiving vaccine with complaints of itching of hands, face, and neck. Patient refused diphenhydramine and stated it was the end of her shift and she was going home.
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| 50 | 2021-01-26 | sensitive skin |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | rash macular, hives, tingling, itchy skin |
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Satur...
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itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
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| 50 | 2021-01-26 | injection site pain |
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel w...
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nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
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| 50 | 2021-01-26 | injection site pain | soreness to injection site, mild headache, mild bodyache |
| 50 | 2021-01-28 | vaccination site pain |
Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report re...
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Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
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| 50 | 2021-01-28 | rash, redness |
Vaccine admin at 12:00 pm. At 12:20 pm, patient developed redness-rash to chest, neck area. 12:25 ...
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Vaccine admin at 12:00 pm. At 12:20 pm, patient developed redness-rash to chest, neck area. 12:25 pm oral Benadryl admin. 12:45 Patient feeling ok. Left vaccination facility with instructions to seek medical services if symptoms re -appear, worsen.
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| 50 | 2021-01-28 | vaccination site pain |
my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck t...
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my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 50 | 2021-02-01 | injection site pain |
Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortnes...
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Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.
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| 50 | 2021-02-07 | itchy skin |
itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels bet...
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itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels better but still itchy; no respiratory issues; no other problems.
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| 50 | 2021-02-10 | injection site pain |
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a conta...
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Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-02-10 | vaccination site pain |
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare...
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Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
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| 50 | 2021-02-11 | blister |
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d...
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reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
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| 50 | 2021-02-21 | tingling, itchy skin |
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do...
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Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
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| 50 | 2021-02-22 | tingling, redness, vaccination site pain |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-22 | rash |
C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg ta...
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C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.
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| 50 | 2021-02-22 | shingles |
Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 ...
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Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.
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| 50 | 2021-02-22 | itchy skin, injection site swelling, hives |
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl...
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Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
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| 50 | 2021-02-25 | itchy skin |
the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain positio...
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the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as "either 22Jan2021 or 23Jan202"), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event "dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side" was not recovered; "the room was spinning/whole room was spinning" was recovered on 26Jan2021 (reported as "went away after a few seconds"); and "her scalp was itching and her back and stomach was itching" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021). Information on lot/batch number has been requested.
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| 50 | 2021-02-28 | tingling |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-03-02 | vaccination site pain |
Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable con...
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Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events. Information on lot/ batch number has been requested.
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| 50 | 2021-03-02 | tingling |
headache on right side of head; back went out from right side and cannot bend over; right leg hurts;...
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headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
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| 50 | 2021-03-09 | rash |
Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for he...
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Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.
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| 50 | 2021-03-09 | vaccination site pain |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-14 | tingling |
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a ...
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more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
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| 50 | 2021-03-21 | tingling |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-04-12 | swelling |
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ...
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pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
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| 51 | 2020-12-31 | injection site pain |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2020-12-31 | tingling |
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe...
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About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
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| 51 | 2021-01-02 | hives | Hives - Benadryl |
| 51 | 2021-01-03 | redness, itchy skin |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-03 | hives |
Patient developed hives that worsened on 12/30/2020. Self treated with topical diphenhydramine cream...
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Patient developed hives that worsened on 12/30/2020. Self treated with topical diphenhydramine cream at home.
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| 51 | 2021-01-04 | rash papular |
Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase ...
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Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730 intramuscular in the left deltoid, from 22Dec2020 15:00 at a, single dose, for COVID-19 immunization. Patient received another Pfizer vaccine on the same date. Medical history included hypertension (HTN), guillain-barre syndrome from 2008. Patient's allergies included penicillin and ASA. Concomitant medication included paroxetine and amlodipine. On 23Dec2020 08:00, approximately 15 small pencil point res bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot. The outcome of events was recovered. no treatment or hospitalization was required. Follow-up attempts are completed. Information on the batch/lot number has been obtained.
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| 51 | 2021-01-04 | tingling |
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav...
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Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
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| 51 | 2021-01-04 | itchy skin, hives | Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting |
| 51 | 2021-01-04 | injection site redness, injection site warmth, injection site pruritus |
Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is l...
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Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is larger PT states she has taken Benadryl for symptoms
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| 51 | 2021-01-04 | tingling |
Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she t...
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Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.
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| 51 | 2021-01-04 | itchy skin |
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning ...
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felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-04 | rash, tingling |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | tingling |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | tingling, vaccination site pain |
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands...
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tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
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| 51 | 2021-01-05 | tingling |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-05 | pain of skin |
Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the s...
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Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the size of a quarter. Seems to be getting larger with the warm compresses, per Dr's orders.
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| 51 | 2021-01-05 | itchy skin |
States that she has experienced generalized itching since receiving first dose of COVID-19. Also s...
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States that she has experienced generalized itching since receiving first dose of COVID-19. Also states that she has noticed her sclerea becoming yellow and skin "jaundice" in color.
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| 51 | 2021-01-05 | tingling |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-06 | rash, itchy skin, hives | Headache, Myalgia, Fever, Rash & Urticaria Pruritus |
| 51 | 2021-01-06 | injection site pain, injection site redness, injection site bruising, rash papular | Large, red, raised, painful injection site reaction with bruising up to 2 weeks later Narrative: |
| 51 | 2021-01-06 | hives |
Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walkin...
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Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.
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| 51 | 2021-01-06 | hives |
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/20...
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Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
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| 51 | 2021-01-06 | rash, itchy skin |
Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiv...
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Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiving COVID vaccine (1st dose) during observation; Epipen given in vaccination room; transferred to R by ambulance. In ER she was given Diphenhydramine 25 mg PO and Famotidine 20 mg PO. Observed for 1-1/2 hours and discharged.
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| 51 | 2021-01-06 | itchy skin, hives |
UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; ...
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UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; VS-126/84;P-76;R-16;SAT-100%; MD at bedside to evaluate. Denies Respiratory difficulties; CP. 1007-Patient states nauseated, RRT at bedside, patient trying to vomit, turned to right side. Dr. from RRT ordered Epi 0.3mg/ml to be given, Epi administered to left thigh, EMS called. 1015- VS; P-69;R-16;BP-110/72, Sat-98, EMS on scene. Patient A & O x4. No difficulty breathing, loaded on EMS stretcher. 1022- VS-127/63; P-73; R-16: Sat-96 and capnography-41. Patient left T205 via EMS at 1022.
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| 51 | 2021-01-06 | itchy skin |
c/o itching palms 15 minutes after immunization that did not travel to any other areas. No other c/o...
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c/o itching palms 15 minutes after immunization that did not travel to any other areas. No other c/o Narrative: Vaccine given at 1410 and c/o itching on palms at 1425. Pt. stated sensation was "faint and subtle, gradually became more noticeable after 15 minutes post vaccination. Cetirizine 10mg, given po at 1440: BP 155/89, P 72, R20, O2Sat. 99%. @ 1500: BP 144/90, 75, 18, 100% o2sat; @ 1510 and prior to discharge: BP 136/85, 79, 18, 100% o2sat. Stated, "it's still itchy but it's feeling better." Denied any breathing difficulty or itching in other areas, except Rt. palm. d/c'd back to work at 1510 in stable condition. RN explained Cetirizine and effects/possible sleepiness/drowsiness.
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| 51 | 2021-01-06 | itchy skin |
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ...
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had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
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| 51 | 2021-01-06 | rash, itchy rash |
severe red rash/hives on bilateral arms. Very itchy. spread drom hands up to shoulders, Benadryl and...
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severe red rash/hives on bilateral arms. Very itchy. spread drom hands up to shoulders, Benadryl and Prednisone taper
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| 51 | 2021-01-07 | vaccination site swelling, vaccination site pain |
Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous rep...
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Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 51 | 2021-01-07 | vaccination site pain |
Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild...
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Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 51 | 2021-01-07 | injection site pain |
On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Tak...
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On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Taken Acetaminophen
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| 51 | 2021-01-07 | injection site bruising, injection site redness |
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ...
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Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
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| 51 | 2021-01-07 | hives |
Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back...
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Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back to work. Patient received 50 mg of diphenhydramine at 14:30, she then started experiencing hives and shortness of breath. She was administer 0.3 mg of epinephrine into the thigh and EMS was called.
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| 51 | 2021-01-07 | injection site redness, injection site swelling |
Redness and swelling at injection site. This happened at the time of injection then went away and ca...
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Redness and swelling at injection site. This happened at the time of injection then went away and came back = 1 week after injection & is still there.
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| 51 | 2021-01-07 | injection site pain |
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,...
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Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
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| 51 | 2021-01-07 | itchy skin |
Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, d...
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Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, denies rash. Patient reports she struggles with allergies and prophylactically medicated prior to first dose with 50 mg of Benadryl and Xytal. Patient reports no adverse reaction after 1st vaccine. Patient reports she prophylactically medicated last night as well but only took 25 mg and no Xytal, patient endorses she believes that is the difference in her symptoms between the first and second dose. Patient endorses allergies to high dose Vitamin D (50,000 units). Patient denies difficulty breath or SOB at this time. Patient reports she is able to move freely at this time. Last day of work and shift - ? currently working at home today Home remedies? - 50 mg Benadryl at 08:00 and Pepcid and Xytal at 11:20 (did not disclose dosage) Any improvement? ? Patient reports mild improvement Recommendation? Patient encouraged to take allergy medication as directed and to call vaccine support if symptoms worsen. Patient educated to call 911 or seek immediate care if any airway issues or difficulty breathing.
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| 51 | 2021-01-07 | injection site pain |
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine...
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Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
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| 51 | 2021-01-07 | injection site pain |
injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site a...
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injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.
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| 51 | 2021-01-08 | redness, itchy skin, tingling |
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ...
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Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
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| 51 | 2021-01-08 | redness, hives | lip swelling, facial hives/erythema, burning |
| 51 | 2021-01-09 | tingling |
1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and...
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1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in
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| 51 | 2021-01-09 | tingling |
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ...
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1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | tingling |
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tin...
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2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | rash papular, injection site pruritus |
4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. ...
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4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. No redness Headache
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| 51 | 2021-01-09 | tingling |
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h...
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Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
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| 51 | 2021-01-09 | injection site swelling |
Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move ...
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Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief
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| 51 | 2021-01-10 | injection site pruritus |
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920...
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0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
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| 51 | 2021-01-10 | injection site pain |
Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m....
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Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m. next day all continued except fever, down to 98 - 99. Pain in my arm is worse, not able to use arm much.
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| 51 | 2021-01-10 | sensitive skin |
I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction...
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I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction on 12/19/20. Horrible fatigue, body aches. My second dose was given on 1/7/21. After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me. Severe fatigue and headache. Took Tylenol with no relief. The worst day hit at 1/8/21 at 3:00 a.m. I could not move without extreme pain. Sweating and chills. No appetite. Had to be assisted to toilet. Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
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| 51 | 2021-01-10 | itchy skin |
Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms ...
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Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.
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| 51 | 2021-01-10 | shingles | Shingles diagnosed on 1/8/2021 in PCP office--may be unrelated to vaccine? |
| 51 | 2021-01-10 | shingles, rash |
Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared Janua...
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Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared January 5th.
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| 51 | 2021-01-10 | injection site inflammation, injection site pain |
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle...
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Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
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| 51 | 2021-01-11 | injection site pruritus, itchy skin |
1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as i...
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1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as injection, 1648 itching inner eyes, monitoring patient another 15 minutes, 1703 no increase in itching, "not any different, not progressing", denies rash, patient left after discussing with NP.
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| 51 | 2021-01-11 | injection site swelling, injection site redness, injection site pain |
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy...
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Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
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| 51 | 2021-01-11 | vaccination site pain |
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ...
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Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
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| 51 | 2021-01-11 | injection site pain |
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ...
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Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
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| 51 | 2021-01-11 | itchy skin |
Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; Thi...
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Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
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| 51 | 2021-01-11 | vaccination site pain, vaccination site itchiness, vaccination site redness |
Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painfu...
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Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; It seemed that it had persisted longer and he said it sounded like it was getting infected; it was painful almost immediately/as a site reaction; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 28Dec2020 injected in unknown arm at single dose for precaution as a front line healthcare worker in hospital. The patient's medical history and concomitant medications were not reported. In the last 9 months, she worked in the COVID unit. It was unknown if additional vaccines administered on same date of bnt162b2. Prior vaccinations within 4 weeks was unknown. Patient said she got the bnt162b2 through her hospital on 28Dec2020, and still had a painful lump on arm that had turned red and itches when she pressed it was reported as worsened on 28Dec2020, it was painful almost immediately, like you would normally get with any vaccination. It seemed that it had persisted longer and he (Sales Representative) said it sounded like it was getting infected. She said it was painful when she pressed on it and he told her not to press on it. Compared to when she had gotten other vaccines in the arm, this seemed out of the ordinary for how long it had been painful as a site reaction. No ER or physician's office required. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 51 | 2021-01-11 | injection site redness, injection site rash | Quarter size red rash at injection site |
| 51 | 2021-01-11 | skin infection at injection site |
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S...
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Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | vaccination site redness, vaccination site swelling, vaccination site pain |
The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness ...
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The swelling started on 31Dec2020 like a knot under the skin at the site of the injection; Soreness in her arm; Redness; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 13:00 at a single dose, for COVID-19 immunization. Medical history included Modular Sponge Kidney stage one (being monitored; this predates her vaccination), Gastrooesophageal reflux disease (GERD), and high cholesterol. Family history included diabetes. Concomitant medications included dexlansoprazole (DEXILANT) from an unspecified date and ongoing for 10 years for GERD, ongoing estrogens conjugated, medroxyprogesterone acetate (PREMPRO) for hormone replacement therapy, pravastatin from an unspecified date and ongoing for 2 years and ezetimibe from an unspecified date and ongoing for six months both taken for high cholesterol. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a drug store.This pharmacy tech received the vaccine on 29Dec2020 at 1300 in the left arm and then had some of the soreness, redness, swelling, and a large knot that grew to the size of a 50 cent piece. It went away and then it came back. She noticed the soreness in her arm and redness at the site on 30Dec2020. The swelling started on 31Dec2020 like a knot under the skin at the site of the injection which grew to the size of a 50-cent piece. The knot went away by the 02Jan2021. Then it started to come back yesterday 05Jan2021 with a knot; and today 06Jan2021 it is also red again and the size of a quarter. Patient is planning to have the second dose on 19Jan2021. She has not treated herself in any way other than rubbing the site. The events did not require emergency or physician visit. Outcome of the events was not recovered. Information on the batch/lot number has been requested.
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| 51 | 2021-01-11 | itchy skin |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | blister, skin burning sensation |
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar...
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erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 51 | 2021-01-11 | itchy rash, rash | rash on both lower legs that was red and itchy that is still there - started 2 days after 1st dose |
| 51 | 2021-01-12 | tingling |
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to ...
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Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
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| 51 | 2021-01-12 | itchy skin, redness |
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d...
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Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
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| 51 | 2021-01-12 | rash |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-12 | injection site swelling, injection site pain |
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min...
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No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
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| 51 | 2021-01-12 | blister |
Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt f...
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Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt flushed in her hands and face. She felt a little short of breath. She started to get fluid-filled blisters on bilateral palms. This is a milder form of the reaction pt has to flu vaccines (she was advised by PCP not to receive flu vaccines because of the blistering). Pt took diphenhyramine 25 mg PO x 1 and the fluid-filled blisters resolved within a few hours. 12/28 around 0330, pt awoke and felt like her right carotid was "pulsating." Pt drank water, did not go back to sleep. "Pulsating" resoved within an hour. No other symptoms develped. In the morning, pt called employee health RN who instructed her to contact PCP and report the reaction. Pt called PCP who advised pt not to get second dose of vaccine due to her reaction to COVID and the flu vaccines.
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| 51 | 2021-01-12 | rash | Rash on neck and torso. |
| 51 | 2021-01-12 | injection site pruritus, hardening, injection site redness, injection site mass |
Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects ...
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Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects about 2am reporting elevated temp of 101, dizziness, muscle aches all over, nausea, and just didn't feel well. She states she developed a knot on her arm at injection site with redness and itching. She reports this knot was hard initially but next day was better. She reports these side effects lasted all weekend.
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| 51 | 2021-01-12 | injection site pain |
Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most t...
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Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most the night, headache, nausea, joint pain starting at 0615 01/12/2021 which continued to get worse through out the day. Left work early 01/12/2021. Woke 01/13/2021 with slight headache still.
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| 51 | 2021-01-12 | tingling, injection site pruritus |
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea...
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Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
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| 51 | 2021-01-13 | tingling |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-13 | tingling |
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se...
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Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
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| 51 | 2021-01-13 | injection site pain |
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f...
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Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
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| 51 | 2021-01-13 | hives |
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea...
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Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
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| 51 | 2021-01-13 | hives, rash |
Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fat...
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Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fatigue Aches first 24 hrs more unusual reaction => starting on day 2, hives/rash over most of the body for <24hrs
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| 51 | 2021-01-13 | injection site pain | Soreness at the injection site, Headache. Treatment: Tylenol, Outcome: No improvement. |
| 51 | 2021-01-13 | injection site redness, injection site pain |
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left a...
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Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
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| 51 | 2021-01-13 | rash | Systemic: Rash (other than injection site)-Mild |
| 51 | 2021-01-13 | bruising |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-14 | injection site swelling, injection site warmth, injection site redness, injection site hardening, injection site pain |
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen...
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2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
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| 51 | 2021-01-14 | sensitive skin |
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ...
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Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
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| 51 | 2021-01-14 | rash, bruising, skin discolouration |
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r...
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On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
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| 51 | 2021-01-14 | injection site swelling, injection site pain |
Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours a...
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Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours after injection, lasting approx 29 hours. Approx 48 hours after injection swollen, tender area approx size of golf ball under left arm ( injection arm) and conintues to be there on 3rd day
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| 51 | 2021-01-14 | vaccination site pain |
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is...
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R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 51 | 2021-01-14 | rash |
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re...
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Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
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| 51 | 2021-01-14 | injection site swelling, injection site redness, injection site pain |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-14 | vaccination site itchiness, itchy skin |
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness...
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Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
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| 51 | 2021-01-14 | injection site pain | Staff member states continued soreness in injected arm 10 days post vaccination |
| 51 | 2021-01-14 | itchy skin | body itching, eye itching and irritation, body warm, chest tightness, bradycardia |
| 51 | 2021-01-14 | itchy skin | body itching, eye itching and irritation, body warmth, chest tightness, bradycardia |
| 51 | 2021-01-14 | vaccination site pain |
soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel li...
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soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm. About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache. She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 51 | 2021-01-17 | vaccination site pain |
Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right ar...
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Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away. It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
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| 51 | 2021-01-19 | itchy skin |
Patient described all over itching approximately 5 minutes after receiving vaccine. Vital signs with...
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Patient described all over itching approximately 5 minutes after receiving vaccine. Vital signs within normal limits. 25 MG IM Benadryl administered
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| 51 | 2021-01-19 | hives |
Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints ...
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Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints of total body urticaria and light headed
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| 51 | 2021-01-21 | injection site pain |
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work...
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I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
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| 51 | 2021-01-21 | injection site pain | Injection site pain, body aches, fatigue, throat pain. Resolved. |
| 51 | 2021-01-21 | rash, itchy skin |
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it...
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Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
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| 51 | 2021-01-21 | injection site swelling |
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1...
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Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
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| 51 | 2021-01-24 | bruising |
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7...
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I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
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| 51 | 2021-01-24 | skin burning sensation, itchy skin |
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir...
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Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
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| 51 | 2021-01-24 | injection site pain | pain at site, joint pain, headache, fever and nausea |
| 51 | 2021-01-25 | tingling |
numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on...
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numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown. Information on the lot/ batch number has been requested.
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| 51 | 2021-01-26 | rash |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-26 | rash | Nausea, fever, bodyaches, headache, fatigue, rash |
| 51 | 2021-01-27 | tingling |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-28 | vaccination site pain |
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a...
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Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
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| 51 | 2021-01-28 | rash macular |
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi...
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Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
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| 51 | 2021-01-28 | tingling |
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;...
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Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
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| 51 | 2021-01-31 | bruising, injection site nodule, injection site swelling |
1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and ...
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1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.
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| 51 | 2021-02-10 | rash, blister, redness |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-14 | skin spots |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-19 | rash, itchy skin, hives |
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate...
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Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
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| 51 | 2021-02-21 | injection site redness, redness, rash | Immediate erythema from injection site down to wrist. Rash on wrist. Resolved in 1-2 hours. |
| 51 | 2021-02-21 | pain of skin |
On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above m...
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On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above my left clavical bone. My neck felt and under my chin felt sore and tender. It is day 9 and I still have the swollen nodes, soreness and tender feeling in neck, shoulder and chin.
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| 51 | 2021-02-21 | tingling, rash |
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi...
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Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
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| 51 | 2021-02-22 | injection site pain |
A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headac...
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A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.
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| 51 | 2021-02-22 | hives, itchy skin |
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensatio...
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Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
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| 51 | 2021-02-25 | vaccination site pain |
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea...
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Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
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| 51 | 2021-03-02 | vaccination site pain |
patient had pain in the arm that she received the vaccine; patient had pain in the arm that she rece...
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patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been obtained.
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| 51 | 2021-03-04 | vaccination site pain |
Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several ho...
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Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered. No follow up attempts are possible. No further information is expected.
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| 51 | 2021-03-16 | rash, injection site pain, itchy skin |
4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. ...
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4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. Ibuprofen and Benadryl 50mg taken. Symptoms resolved. 5 days later, tinnitus in right ear occurs and has been ongoing since then.
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| 51 | 2021-03-18 | tingling, hives, itchy skin, vaccination site redness, vaccination site pain, rash macular, vaccination site warmth, redness |
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu...
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Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
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| 52 | 2021-01-01 | injection site pain |
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2...
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12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
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| 52 | 2021-01-02 | swelling, itchy skin |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-03 | rash, rash papular | Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face) |
| 52 | 2021-01-03 | hives, injection site hives, redness | Hives on left arm close the injection site. Hives and skin redness on upper chest between breasts |
| 52 | 2021-01-03 | injection site pain | Nausea, headache, muscle ache, exhaustion, chills, low grade fever, and pain at the injection site. |
| 52 | 2021-01-03 | itchy skin, rash |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
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| 52 | 2021-01-03 | injection site rash, injection site redness |
injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ank...
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injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ankle cough
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| 52 | 2021-01-04 | rash | Lower right leg skin rash. Localized size of Quarter |
| 52 | 2021-01-04 | blister |
Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to ...
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Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to neck, chest and abdomen, chest pain, and elevated blood pressure. Patient states she is already on cardiac medications so she took an additional dose for her blood pressure and monitored herself closely.
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| 52 | 2021-01-04 | tingling |
intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and...
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intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
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| 52 | 2021-01-04 | injection site pain |
within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was m...
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within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.
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| 52 | 2021-01-05 | injection site pain, injection site warmth, injection site swelling | Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful |
| 52 | 2021-01-05 | injection site pain |
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ...
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Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
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| 52 | 2021-01-05 | tingling |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | injection site swelling, injection site pain | Pain and swelling on injection site, Cold chills, headache and fatigued |
| 52 | 2021-01-05 | rash | Rash on right torso (belt line) side of the back of and front of thighs and buttocks |
| 52 | 2021-01-05 | tingling |
Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on star...
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Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.
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| 52 | 2021-01-06 | rash, redness, itchy skin |
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon re...
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Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.
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| 52 | 2021-01-06 | injection site pain |
Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin wit...
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Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin with some relief.
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| 52 | 2021-01-06 | injection site rash |
Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of all...
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Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of allergies). Transferred to ED
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| 52 | 2021-01-07 | injection site redness, injection site hives, itchy skin |
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i...
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12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
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| 52 | 2021-01-07 | injection site pain | Injection site pain Muscle pain Headache Fatigue |
| 52 | 2021-01-07 | rash, rash macular | Mid back pain, Right hip numbness, macular rash on administered arm |
| 52 | 2021-01-07 | injection site redness, injection site pain, injection site swelling |
Pain, redness and swelling in right arm after Covid vaccine administered in incorrect injection site...
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Pain, redness and swelling in right arm after Covid vaccine administered in incorrect injection site.
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| 52 | 2021-01-07 | pain of skin |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-08 | injection site pain | - Strong injection site pain extending to neck and shoulder area |
| 52 | 2021-01-08 | redness |
ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/9...
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ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative: Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.
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| 52 | 2021-01-08 | tingling |
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r...
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HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
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| 52 | 2021-01-08 | itchy skin |
Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds...
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Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds clear. administered 25mg Benadryl + 40mg Pepci AC patient left under own accord. 61 y/o female who presents with (L) arm itching shortly after her vaccine, no other symptoms. No significant Physical findings Probable localized allergic rxn.
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| 52 | 2021-01-08 | hives, itchy skin | UrticariaPruritus Narrative: Employee self treating with benadryl. It started on 1/5/21 |
| 52 | 2021-01-09 | rash | Turned red in upper torso, swelling to tongue and heightened blood pressure. |
| 52 | 2021-01-10 | itchy skin |
Received 2nd dose Pfizer Lot EL0142 in right arm. About 15 minutes after receiving dose, she started...
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Received 2nd dose Pfizer Lot EL0142 in right arm. About 15 minutes after receiving dose, she started to develop itch in right forearm and nose
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| 52 | 2021-01-10 | tingling | Went into the ED for bilateral hand and feet tingling. Worked up for possible Guillain Barre. |
| 52 | 2021-01-10 | rash macular | red, blotchy rash. Given 50 mg Benadryl po |
| 52 | 2021-01-10 | blister |
within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-fill...
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within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021
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| 52 | 2021-01-11 | tingling |
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye...
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Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
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| 52 | 2021-01-11 | vaccination site swelling, vaccination site redness, vaccination site pain |
Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injecti...
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Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
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| 52 | 2021-01-11 | vaccination site pain |
Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at th...
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Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
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| 52 | 2021-01-11 | hives | Hives, patient monitored |
| 52 | 2021-01-11 | injection site redness, injection site pain, injection site swelling |
Injection site swelling, burning, redness, pain post injection to current day still pain, swelling a...
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Injection site swelling, burning, redness, pain post injection to current day still pain, swelling and burning
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| 52 | 2021-01-11 | rash |
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir...
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Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
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| 52 | 2021-01-11 | injection site redness, injection site pain, injection site pruritus, injection site rash, rash |
Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on ...
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Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on upper arm near injection site and across chest, collar bone, neck and chin. Took Benedryl , Allegra, and Tylenol for 24 hours. Symptoms mostly resolved by 4:00pm on 1/8/21.
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| 52 | 2021-01-11 | redness |
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh...
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Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
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| 52 | 2021-01-11 | tingling |
injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp ti...
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injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp tingling/burning over the medial clavicle and extending into the neck. there was no rash, redness, swelling, swallowing or breathing difficulty. At 21 days, I am still experiencing hyperaesthesia and some tingling over the medial clavicle, and a zinging sensation over the clavicle/sternoclavicular joint with L shoulder movement, valsalva or burping. evaluation on site by vaccine provider. telephone consultation with PCP 2 days and 1 week later, and brief telephone consultation with local allergist. gabapentin for discomfort
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| 52 | 2021-01-11 | itchy skin, injection site swelling, injection site warmth |
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ...
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injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
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| 52 | 2021-01-11 | injection site swelling, injection site pain, injection site mass |
swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla,...
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swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla, starting approximately starting 45 hours post injection and continuing at time of this report
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| 52 | 2021-01-11 | injection site pain |
woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/...
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woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/joint pain that made it difficult to get out of bed. Nausea and low grade fever. Unable to go into work. Felt I was not able to get out of bed to even take medication. Fianlly took 600mg of ibuprofen at 1:30 p.m. Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued. Slept well then next night and felt 90% better the next morning. Feeling much better today. No s&s.
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| 52 | 2021-01-12 | redness |
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face b...
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After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
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| 52 | 2021-01-12 | injection site pain |
I had a mild headache the evening of the shot, I had a headache the next two days that was relieved ...
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I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.
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| 52 | 2021-01-12 | pain of skin | Insomnia, headache, fever, aches, skin pain |
| 52 | 2021-01-12 | rash, rash papular, hives |
Patient developed red rash (hives) with raised wheals covering almost all of anterior chest and abdo...
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Patient developed red rash (hives) with raised wheals covering almost all of anterior chest and abdomen within 1 hour after receiving the vaccine. There has been no rash on back, legs, or arms. No reaction at the injection site. No other symptoms. Patient will take benadryl 25 mg orally three times daily (starting tonight) and use hydrocortisone 1% cream topically three times daily (starting tonight). Outcomes are yet to be determined. Will continue to monitor.
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| 52 | 2021-01-13 | rash |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-13 | skin burning sensation |
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu...
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Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
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| 52 | 2021-01-13 | itchy skin | generalize papular rash; very itchy, 4 days post vaccine, lasted 48hrs; treated with Benadryl |
| 52 | 2021-01-14 | injection site tingling, tingling |
23 minutes after the patient receive the shot she complained of tingling at the site and down her ar...
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23 minutes after the patient receive the shot she complained of tingling at the site and down her arm. Provided patient with 2 25mg Benadryl to self administer. Upon checking at 1pm and 7:00pm patient was feeling better.
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| 52 | 2021-01-14 | skin spots, rash |
A petechial rash developed on my bilateral palms of hands, left greater than right, on 01/10/2021. ...
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A petechial rash developed on my bilateral palms of hands, left greater than right, on 01/10/2021. There was no rash noted on my feet or body habitus. When the lesions became darker and more punctate , decision was made to seek medical attention. There was no history of trauma, fever, or skin injury. I saw my Internist, on 01/14/2021 for evaluation and treatment.
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| 52 | 2021-01-14 | tingling |
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of...
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About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm. Vital signs within normal limits. Patient improved.
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| 52 | 2021-01-14 | rash, skin burning sensation, blister, redness, itchy skin |
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b...
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Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
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| 52 | 2021-01-14 | injection site hardening |
Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Le...
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Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Left arm induration of 15-20cm noted 1/15/21 at 8am
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| 52 | 2021-01-14 | injection site pain |
Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination....
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Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination. Still experiencing as of 1/15/2021. On 1/14/2021 experienced throbbing under ear to jaw bone.
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| 52 | 2021-01-14 | injection site warmth, injection site redness, injection site pain, injection site pruritus | injection site is red 9cm down my arm, warm to the touch, itchy, and sore |
| 52 | 2021-01-15 | tingling |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-16 | injection site pain |
101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection sit...
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101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection site.
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| 52 | 2021-01-16 | injection site redness |
Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache las...
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Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache lasted 3 days , chills intermittent for several days fatigue still have
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| 52 | 2021-01-16 | redness | Redness over face/arms |
| 52 | 2021-01-16 | injection site pain | headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness |
| 52 | 2021-01-16 | redness |
received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on f...
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received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on face and chest. Came back to building for additional observation at 1400. Given Benadryl and observed.
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| 52 | 2021-01-17 | rash |
Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hou...
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Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination. Treated with acetaminophen and ibuprofen. On 1/14/2021, forty-eight (48) hours after the vaccine administration, rash appeared on trunk and neck. Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone. Rash persisted for 24-36 hours.
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| 52 | 2021-01-19 | itchy skin |
About 6 hrs after vaccine, I started itching down around my ankles and it kept getting worse and it ...
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About 6 hrs after vaccine, I started itching down around my ankles and it kept getting worse and it spread and into the next day. I tried to deal with it with Benadryl for 5 days Urgent Care and was given: 4 - Zyrtec and -2- Xantac : took that once a day for two days. Symptoms started resolving after that. Still had itching for 3-4 days after that but it was mild and then it went away. Went to my Rheumatogist and he said to take Prednisone but I didn't.
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| 52 | 2021-01-19 | rash |
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE...
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RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
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| 52 | 2021-01-21 | rash |
2 HOUR AFTER VACCINE EMPLOYEE DEVOLOPED RASH ON LEGS AND ARMS PERSISTED UNTIL ATLEAST 1/14/20201, M...
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2 HOUR AFTER VACCINE EMPLOYEE DEVOLOPED RASH ON LEGS AND ARMS PERSISTED UNTIL ATLEAST 1/14/20201, MAY STILL BE ON GOING.
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| 52 | 2021-01-21 | rash |
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d...
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52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
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| 52 | 2021-01-21 | itchy skin, rash |
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI...
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GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
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| 52 | 2021-01-21 | rash |
Under my left breast/ upper stomach area, I developed a rash about the size of a quarter. The rash i...
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Under my left breast/ upper stomach area, I developed a rash about the size of a quarter. The rash is painful with small like blisters, which after sleeping on my stomach appeared to have removed any fluid. As of today, 1/22/21, is looks like the rash attempting to heal but very sore.
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| 52 | 2021-01-21 | injection site hardening |
after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day...
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after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day and felt like it came and went very quickly. the injection site was still hard and edematous after about 2 weeks. After the second vaccine I became slightly achy the same day I got the shot but pre-emptively took ibuprofen, which worked well. it wasn't until the day after my shot (towards the end of my work day) that I became incredibly fatigued and muscles ached. Later in the evening I developed a sore throat and slight cough, I did not take my temperature but felt I had a slight temperature increase. the 2nd and 3rd day post shot I was incredibly fatigued with a slight sore throat. by 4th day post shot I was feeling back to my normal self.
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| 52 | 2021-01-21 | hives, injection site hives, itchy skin |
hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. ...
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hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. Itching. later feeling fatigue, body aches and headache.
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| 52 | 2021-01-21 | tingling |
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ...
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immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
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| 52 | 2021-01-22 | tingling |
paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten...
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paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten worse - just a mild tingling sensation) - no pain
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| 52 | 2021-01-24 | injection site swelling |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | pain of skin |
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide...
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Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
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| 52 | 2021-01-24 | skin spots |
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec...
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headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
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| 52 | 2021-01-25 | vaccination site swelling, vaccination site redness, vaccination site warmth |
Mild swelling (2" x 1" area) near injection site on left deltoid area; noticeable redness and warm t...
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Mild swelling (2" x 1" area) near injection site on left deltoid area; noticeable redness and warm to touch; noticeable redness and warm to touch; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284) via an unspecified route of administration at left arm (deltoid), on 06Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient did not have COVID prior vaccination. Concomitant medication included tocopherol (VITAMIN E). Patient did not receive other vaccine in four weeks. Patient experienced mild swelling (2" x 1" area) near injection site on left deltoid area, noticeable redness and warm to touch, appeared 8 days after injection on 14Jan2021 05:00. No treatment received. No COVID tested post vaccination. Outcome of the events was not recovered.
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| 52 | 2021-01-25 | injection site warmth, injection site redness, injection site swelling |
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and war...
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On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
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| 52 | 2021-01-25 | rash | Systemic: Rash (other than injection site)-Mild; symptoms lasted 2 days |
| 52 | 2021-01-26 | redness | Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing |
| 52 | 2021-01-28 | tingling |
1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c...
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1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
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| 52 | 2021-01-28 | itchy skin, redness |
Patient experienced redness/itching on neck/upper back during 15 minute monitoring period and was ke...
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Patient experienced redness/itching on neck/upper back during 15 minute monitoring period and was kept for an extra 15 minutes, in which this improved. Patient received first dose Pfizer lot# EK 5730 in 12/17/2020.
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| 52 | 2021-01-28 | skin spots |
Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old f...
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Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
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| 52 | 2021-01-28 | hives | Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting |
| 52 | 2021-01-31 | hives |
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest...
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Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
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| 52 | 2021-02-02 | injection site inflammation, injection site warmth, injection site redness |
At the moment of the vaccination it didn't have any incidents, but during the night she touched her ...
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At the moment of the vaccination it didn't have any incidents, but during the night she touched her left arm and feeled a bump (inflammation, edema on the injection site) at the next day she continue to have the edema and redness area. After these days I continued noticing her arm hot to touch and the edema.
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| 52 | 2021-02-21 | injection site swelling |
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap...
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02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
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| 52 | 2021-02-21 | skin spots |
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s...
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16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
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| 52 | 2021-02-21 | injection site pruritus, injection site swelling | Itching, swelling at injection site, pain, heart palpitations, lymph node swelling |
| 52 | 2021-02-21 | rash |
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mi...
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Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
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| 52 | 2021-02-21 | rash, itchy skin |
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t...
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ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
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| 52 | 2021-02-22 | itchy skin | Burning itchness all over body |
| 52 | 2021-02-22 | rash |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-22 | hives, itchy skin |
Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itch...
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Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itching, and SOB since receiving her Covid-19 vaccine 3 weeks ago. Got the Pfizer vaccine at the Center on 1/17/21 around 12:30PM. She had no side effects during the 15 minutes she was kept for observation after receiving the vaccine. She did develop a headache and fatigue approximately 1.5 hours after she got the vaccine and then later that day developed nausea. SOB developed the following day. She developed hives on her chest approximately 2-3 days after the vaccine. States she cannot recall the exact date that the hives started. Hives have appeared like pink raised plaques. Largest plaque was 1 inch in diameter she estimates. The hives have continued to come and go from different areas of her body including her shoulders, buttock, upper legs. SOB is present at rest and with exertion. She has had no chest pain/pressure/tightness/wheezing , palpitations, or feeling of her throat closing. States her exertion capacity is reduced.
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| 52 | 2021-02-22 | redness, rash |
Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright ...
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Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich
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| 52 | 2021-02-22 | itchy rash |
Recipient reports itching left arm and rash on left arm noted the day after receiving the vaccine....
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Recipient reports itching left arm and rash on left arm noted the day after receiving the vaccine. She added that the itching is gone and no new bumps have appeared.
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| 52 | 2021-02-23 | injection site tingling | Tingling in left shoulder blade and left arm |
| 52 | 2021-02-24 | redness, itchy skin, vaccination site redness |
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ...
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Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
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| 52 | 2021-03-01 | tingling |
Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still ...
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Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still here. I can't feel anything below my knees and have weekness in my hands. I can't walk and have difficulty moving my legs. Doctors are saying that they don't know if I will ever walk again.
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| 52 | 2021-03-02 | rash |
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a...
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chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
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| 52 | 2021-03-04 | vaccination site swelling, vaccination site pain, vaccination site redness, vaccination site warmth |
palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; ...
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palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event "Soreness for 2.5 days" was recovered; "She felt pain immediately from the injection", "it is red and bruised/Redness" was recovering; and "bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple", "Warm to touch/feels hot to touch" and "Swelling in the injection area" was not recovered, and for palpitations was unknown.
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| 52 | 2021-03-09 | vaccination site pain, vaccination site warmth, vaccination site redness |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | vaccination site pain |
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ...
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she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-30 | vaccination site swelling |
Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache;...
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Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache; Lower body jont pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 52-year-old non-pregnant female patient, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL 3248), via an unspecified route of administration in the left arm on 26Jan2021 at 02:00 PM (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history included gadolinium contrast (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 27Jan2021 at 05:30 AM the patient exepreienced fever over 100, severe headache, lower body joint pain, injection site rash and swelling. The event were assessed as non-serious by the reporter. No treatment was received for the events. Outcome of the events were recovering.
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| 53 | 2021-01-03 | redness |
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, ...
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After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health
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| 53 | 2021-01-03 | itchy skin |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | rash papular, injection site reaction, injection site pain |
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende...
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I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
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| 53 | 2021-01-03 | rash |
Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on h...
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Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on hands and sole of her feet onsetting 01/01/2021. Per patient, she took OTC allergy medication and applied OTC Cortizone onto hands and feet. Pateint denies sypmptomes of headcaches, fever, diarrhea, or nausea.
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| 53 | 2021-01-03 | tingling |
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu...
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Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
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| 53 | 2021-01-03 | itchy skin |
With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I st...
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With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.
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| 53 | 2021-01-04 | injection site pain |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | tingling | Numbness and tingling in fingers and hand of same arm the vaccine was given in. |
| 53 | 2021-01-04 | rash, itchy rash |
On 12/28 started with itchy rash on left side of body. Arm, hand, leg, foot. Then started on lips ...
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On 12/28 started with itchy rash on left side of body. Arm, hand, leg, foot. Then started on lips and inside mouth. Did go to left arm. Started on prednisone 12/31 prescribed by my PCP. Using pepcid and Zyrtec as well as benadryl cream. Have completed 5 days of 30mg prednisone and 1 day of 20mg prednisone and rash remains. Continues to itch. Mouth is better but left side of body no better. Did have shot in left arm. Have changed nothing and no new food. Spoke to several doctors at the hospital that I work at and they are worried that it is from covid vaccine.
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| 53 | 2021-01-04 | vaccination site redness, vaccination site swelling, vaccination site pain |
Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reacti...
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Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 19Dec2020 at 10:15 AM in a hospital at a single dose for COVID-19 immunization. Medical history included asthma and GERD. The patient was not pregnant at the time of vaccination and had no known allergies. The patient had no other vaccine in four weeks, had no COVID-19 diagnosis prior to vaccination, and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole (PRILOSEC). On 27Dec2020 at 18:00, the patient experienced a recurrence of redness, swelling, and pain at injection site measuring 5.5 cm x 5.6 cm occurring on day 9 post injection. Site reaction was identical to the initial reaction occurring on days 2 and 3 of Dec2020, which resolved by day 4. The patient received no treatment for the events. Outcome of the events was not recovered/not resolved. Information about the lot/batch has been requested.
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| 53 | 2021-01-04 | rash |
The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe heada...
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The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic. Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering). There was non other vaccine in four weeks and no other medications in two weeks. The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen. The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
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| 53 | 2021-01-04 | rash | Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB |
| 53 | 2021-01-04 | tingling |
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th...
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feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
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| 53 | 2021-01-04 | vaccination site pain |
fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This ...
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fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
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| 53 | 2021-01-04 | hives |
urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient)....
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urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 16Dec2020 21:00 at a single dose for COVID-19 immunization at the workplace clinic. Medical history included sulfa allergies. Concomitant medication included ibuprofen. The patient had not received other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced urticaria on the chest and leg on 24Dec2020 20:00. Outcome of the event was not recovered; no treatment was given for the event. The patient was not diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 53 | 2021-01-05 | injection site pain |
Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, he...
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Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; This is a spontaneous report from a contactable Nurse (Patient). A 53-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ej1685) , via an unspecified route of administration on 22Dec2020 11:00 at first single dose at arm left for covid-19 immunisation . Medical history included iodine allergy. Concomitant medication included fish oil. The patient experienced Chills, muscle/joint pain, headache, injection site pain, fever 103.9 on 22Dec2020 21:00. Therapeutic measures were taken as a result of events was Ibuprofen. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
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| 53 | 2021-01-05 | injection site redness, injection site pruritus, injection site swelling, injection site warmth |
Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020...
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Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020. Arm at injections site red swollen, hot to touch and itchy.
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| 53 | 2021-01-05 | rash |
intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pe...
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intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pepcid Outcome: next morning symptoms gone.
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| 53 | 2021-01-06 | injection site reaction |
Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been ...
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Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been given, a headache and back ache. She did go to the chiropractor on 1/4, but states it did not help. She saw an allergy specialist on 1/5. As of 1/7/20 0830am she still had a headache.
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| 53 | 2021-01-06 | tingling | Bells Palsy?left facial droop and left facial numb/tingling |
| 53 | 2021-01-06 | injection site swelling, injection site pain, injection site redness |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-06 | injection site pain, injection site bruising |
Very achy and tired the following day. very tender at injection site for three days following inject...
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Very achy and tired the following day. very tender at injection site for three days following injection. Bruising at injection site.
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| 53 | 2021-01-07 | rash, redness |
Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. ...
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Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. Rash lasted a couple of days.
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| 53 | 2021-01-07 | redness, hives, rash macular, itchy skin |
Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-1...
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Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-19 vaccination. Reported that she had taken Benadryl 50mg PO after first vaccination. Pt reported today 1/7/20, she took medication prior to COVID-19 vaccination: Pepcid 40mg PO at 1626. Benadryl 25mg PO at 1626. 1810: pt c/o scalp itching, visible redness to itchy area on scalp. BP 158/84 (101), HR 82, regular rhythm, SpO2 97%, RR 18, Temp=97.5F 1812: 25mg Diphenhydramine HCL oral solution given PO for itching to scalp. 1818: BP 159/93 (108), HR 78, regular rhythm, SpO2 98%, RR 17, Temp =98 F 1822: Splotchy redness noted to pt's L lower arm, no itching. Redness noted to L upper chest with pt c/o itching to L upper chest area, R neck, nose and R toes itching. Pt denies difficulty breathing, swallowing. SpO2=98% 1830: BP 172/84 (105), HR 82, regular rhythm, SpO2 100%, RR 16, Temp=97.5 F Pt denies any new areas of itching, scalp, R toes, R neck and R chest area still itchy. No c/o difficulty swallowing or breathing. No throat clearing. 1837: pt notes improvement in scalp and nose itching. Redness to L arm and chest improved. 1845: BP 165/80 (102), HR 85, regular rhythm, RR 16, SpO2=99%, Temp =98.2 F Pt c/o itching again to R side of scalp with redness noted to scalp. 1850: 25mg Diphenhydramine HCL oral solution given PO for itching and redness to scalp. 1900: BP 153/87 (104), HR 85, regular rhythm, RR 12, SpO2=98%, Temp=97.6 F Pt reports mild scalp itching with some improvement since second dose of diphenhydramine. No other itching or redness noted. 1915: BP 171/86 (107), HR=80, regular rhythm, RR 12, SpO2=99%, Temp=97.4 F pt reports mild itching to L scalp and L chest, no significant redness noted. 1930: Pt denies worsening symptoms, no additional itching or redness. Gave pt discharge instructions to not exceed 100mg of Diphenhydramine in a 4 hour period. Recorded times and amounts of diphenhydramine given during post vaccine monitoring period. Pt denies feeling drowsy and is comfortable driving home. Directed patient to call emergency services from home with any worsening of rash or trouble breathing, feeling faint, or any other concerning symptoms. Pt's husband will be at home with pt, aware of additional monitoring needed post vaccine.
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| 53 | 2021-01-07 | tingling, itchy skin | Felt severe itching pins needles on arms, wrists, chest & neck. |
| 53 | 2021-01-07 | vaccination site pain |
Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (...
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Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 53 | 2021-01-07 | redness |
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I...
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My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
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| 53 | 2021-01-07 | injection site warmth, injection site swelling, injection site redness, injection site pain | Upper left arm at injection site red, swollen, warm and pain. Area swollen approximately 7cm. |
| 53 | 2021-01-07 | vaccination site pain |
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ...
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felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
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| 53 | 2021-01-07 | vaccination site pain |
mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous ...
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mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received bnt162b2 (BNT162B2; Pfizer-Biontech Covid-19 Vaccine also reported as vaccine A (Pfizer Ultracold); lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 22Dec2020 09:15 at a single dose for covid-19 vaccination. Medical history included anxiety and depression. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other medications received within 2 weeks of vaccination. The patient most recent COVID-19 vaccine was administered a hospital. It was reported that 7 hours after vaccination (22Dec2020 04:15 PM [reported as 04:00PM]), the patient experienced mild pain at the injection site, tiredness, chills, headache, and feeling unwell. All resolved within 12 hours after sleep (23Dec2020 04:15). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 23Dec2020 04:15.
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| 53 | 2021-01-07 | vaccination site pain |
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s...
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neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-07 | rash papular, rash |
no reaction or side effects at time of injection; then 5 days later on 1/4 developed red bump on rig...
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no reaction or side effects at time of injection; then 5 days later on 1/4 developed red bump on right forearm that progressed to rash on both forearms, upper legs and torso; no itching pain, swelling of diff breathing
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| 53 | 2021-01-08 | injection site swelling |
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes...
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1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
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| 53 | 2021-01-08 | injection site pain |
Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at...
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Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at the shoulder. This was more than muscle soreness but being unfamiliar with Covid vaccine, I just rode it out. This lasted 2 days. Since then, my shoulder joint has not been the same with sl limited ROM and persistent pain. This improved signif over the 3 weeks until my 2nd Covid vaccine 1/7/21. This is what tipped me off that the first shot was not correct. #2 did not burn at all with administration or cause any limited ROM. Typical deltoid soreness sl more than a tetanus shot, and general "flu like sxs" that lasted < 24 hours.
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| 53 | 2021-01-08 | injection site pain, injection site swelling |
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling a...
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Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.
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| 53 | 2021-01-09 | injection site pain |
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn...
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Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
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| 53 | 2021-01-09 | injection site pain | Pain at injection site, fever, sweating and worsening headache |
| 53 | 2021-01-10 | rash |
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (t...
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(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
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| 53 | 2021-01-10 | injection site pain |
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever...
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1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
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| 53 | 2021-01-10 | injection site swelling, injection site warmth, injection site pain |
5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temper...
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5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temperature up to 101.5. On 1/8, temperature resolved, still bodyaches. On 1/9, symptoms resolving, but at 12:00pm temperature of 99.9 and fatigue. On 1/10 right deltoid where vaccine was administered, sight is warm to touch and swollen, painful.
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| 53 | 2021-01-10 | tingling |
A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have ...
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A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have had Bell's Palsy in the past (30 years ago)
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| 53 | 2021-01-10 | injection site pain | Body aches, chills, injection site soreness |
| 53 | 2021-01-10 | injection site swelling, injection site pain |
Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with impr...
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Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with improvement.
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| 53 | 2021-01-10 | hives, rash, redness, rash papular |
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red...
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Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 53 | 2021-01-10 | redness |
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n...
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chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 53 | 2021-01-11 | injection site swelling, injection site pruritus, injection site redness, injection site warmth |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | injection site tingling |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | rash, redness |
Day after receiving dose, experience a red bump on knee. Day after that additional 10-12 red bumps o...
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Day after receiving dose, experience a red bump on knee. Day after that additional 10-12 red bumps on both legs, forearms and 1 on forehead. Very itchy and painful. Used calmine lotion. As of today 1/12/21 symptoms improving.
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| 53 | 2021-01-11 | rash | Developed over all body rash on 1/9/2021 |
| 53 | 2021-01-11 | redness, hardening | I have a red silver dollar sized hard lump that is red and warm |
| 53 | 2021-01-11 | injection site mass, injection site redness, injection site hardening, injection site warmth | I have a silver dollar size hard lump at injection site, it is red and warm. |
| 53 | 2021-01-11 | injection site pain |
Insatiable hunger, sore injection area. Hunger lasted for four days. Soreness at injection site la...
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Insatiable hunger, sore injection area. Hunger lasted for four days. Soreness at injection site lasted about 12 hours
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| 53 | 2021-01-11 | tingling |
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug...
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Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
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| 53 | 2021-01-11 | injection site pruritus |
Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed f...
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Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed for 30 minute observation, at observation completion patient reports she was also feeling slightly dizzy and lightheaded, reports those symptoms were occurring intermittently throughout 30 minute wait. Patient offered oral fluids (water/juice), and to stay a little longer, patient refused, reports she is fine to go home. Patient left observation on her own.
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| 53 | 2021-01-11 | tingling, shingles |
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sens...
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Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
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| 53 | 2021-01-12 | redness, itchy skin |
1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:...
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1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:30 PM ON 1/11/21 AND SYMPTOMS BEGAN WITH BEING AWAKENED BY FEELING ITCHINESS ON STOMACH AT APPROX 01:30 A.M. ON 1/13/21. PATIENT (I) OBSERVED BUMPINESS AND REDNESS COVERING ENTIRE STOMACH, BACK OF NECK AND ITCHINESS DOWN THIGHS AND ALONG UNDER SIDE OF ARM. TOOK BENADRYL OTC AND WENT BACK TO BED. AWOKE FOR WORK AT 04:30 AND SYMPTOMS ARE BETTER. NO SHORTNESS OF BREATH OR OTHER ALLERGY RELATED SYMPTOMS
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| 53 | 2021-01-12 | injection site pain |
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,...
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After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
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| 53 | 2021-01-12 | redness |
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo...
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Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
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| 53 | 2021-01-12 | injection site pain, injection site swelling, injection site inflammation | PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS. |
| 53 | 2021-01-12 | rash, injection site pain, injection site swelling |
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j...
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Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
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| 53 | 2021-01-13 | itchy skin, blister |
1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Mo...
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1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Morning of 1/5/21 sole of left foot in arch area began to itch. Upon a visual check a red rash is present approximately 1.5"-2" in diameter on the soles of both feet in the arch area. 1/6/21 blisters formed in rash area of the right foot. On 1/8/21 upon patient visiting her dermatologist, the rash was ruled out as not being caused by a bacterial infection or fungal infection. Dermatologist prescribed an antihistamine oral medication and a steroid cream. 1/9/21 patients reports burning and itching increased and she used a frozen foot roller to treat the burning and itching. 1/10/21 Patient states that itching and burning subsided and discontinued use of steroid cream. Patient continues to take oral antihistamine (Hydroxyzine HCL 25mg) prescribed by dermatologist . Patient reports there have been no changes in soaps or detergents being used and no changes in behavior prior to vaccination and therefore, patient and doctor can, but without certainty, conclude that the rash is a result of the COVID-19 vaccination. 1/11/21 patient took pictures of rash and are available for viewing. As of 1/14/21 rash still present but itching has stopped. This event is a non-severe adverse event. Patient is scheduled to receive second dose of vaccination on 1/25/21. Patient has been advised to take antihistamine prior to receiving second dose of vaccination and again 12 hours following the 2nd dose of vaccination.
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| 53 | 2021-01-13 | rash, itchy skin |
1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of r...
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1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of right foot in arch area. Morning of 1/5/21 itching began on sole of left foot in arch area. Patient look at both feet and noticed a red rash on soles of both feet in arch area approximately 1.5" - 2" in diameter. 1/6/21 blisters developed on right foot in rash area. 1/8/21 patient went to dermatologist; the dermatologist ruled out bacterial and fungal infections. Dermatologist prescribed a topical steroid lotion and an oral antihistamine (Hydroxyzine HCL 25mg). 1/9/21 patient reported severe burning and itching of both feet and self-treated with a frozen foot roller which successfully subsided the burning and itching. 1/10/21 discontinued use of steroid lotion. Continues to take oral antihistamine. 1/11/21 blisters are gone but rash is deep red and still exists as of today without itching or burning.
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| 53 | 2021-01-13 | injection site pain, injection site redness, injection site swelling |
Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience i...
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Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience increase of temperature and fatigue.
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| 53 | 2021-01-13 | injection site pruritus, injection site pain |
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ...
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FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
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| 53 | 2021-01-13 | itchy skin |
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ...
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Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 53 | 2021-01-13 | injection site pain |
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ...
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I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
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| 53 | 2021-01-13 | rash |
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a...
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Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
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| 53 | 2021-01-13 | tingling |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-13 | rash, itchy rash |
Pt noted rash on (L) knee, progressed to both thighs, lower back and both arms. Now also on bith arm...
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Pt noted rash on (L) knee, progressed to both thighs, lower back and both arms. Now also on bith arms, upper back and ears, and both legs. Very itchy.
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| 53 | 2021-01-13 | itchy skin, hives, skin discolouration |
Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very...
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Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very itchy. On Sunday I had hives on my upper legs, stomach, buttocks and my ears were swollen and purple. went to urgent care 1/2/2021. Gave me prednisone 40mg for 5 days and triamcinolone cream.
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| 53 | 2021-01-14 | injection site swelling, sensitive skin, redness |
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on ch...
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3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
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| 53 | 2021-01-14 | itchy skin |
At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruri...
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At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruritus Benadryl 50ml IM were administrated. Vital signs Oxygen saturation 95%, HR 85bpm, BP 155/91mmHg, Dxt 119 and RR 12 rpm. At 1:45pm patient complaint of fatigue, an Rapid Response (RR) code for anaphylactic reaction was activated. Patient received Epinephrine 0.3mg IM (1 dose), Solu-Cortef 200mg IM (1 dose) and was transferred to the ER per anaphylactic shock protocol. Vitals signs at ER were 132/76mmHg, RR 14rpm, Osat 99% and HR 83bpm.
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| 53 | 2021-01-14 | vaccination site redness, vaccination site warmth |
Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot a...
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Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
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| 53 | 2021-01-14 | injection site nodule, injection site pain |
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ...
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Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
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| 53 | 2021-01-14 | rash, hives | Hives across face and upper torso, arms. |
| 53 | 2021-01-14 | vaccination site pain |
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ...
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Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 53 | 2021-01-14 | tingling |
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in...
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fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-14 | tingling |
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan...
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shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 53 | 2021-01-15 | injection site pain, injection site hardening |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-15 | hives |
Mild hives and wheezing one hour after second dose of vaccine. Employee health provider administered...
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Mild hives and wheezing one hour after second dose of vaccine. Employee health provider administered 25 mg Benadryl IM with relief. I have needed to use albuterol daily since which is unusual for me.
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| 53 | 2021-01-15 | tingling |
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min...
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Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
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| 53 | 2021-01-16 | itchy skin, hives, redness | Hives on both arms redness itching burning |
| 53 | 2021-01-16 | tingling |
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower...
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I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
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| 53 | 2021-01-16 | tingling |
I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later,...
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I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later, my entire upper arm began aching-pain from my trapezius down to my elbow. This continued throughout the weekend and then Monday, my index and middle finger began tingling (as if asleep). This symptom has never subsided. I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist. I have tired trigger injections in my trapezius, ibuprofen, muscle relaxers, heat, exercises, a steroid burst-all without relief of symptoms. I am able to move my arm and I do have strength in the extremity. I have seen a specialist in physical medicine and rehabilitation. What I believe may have triggered this reaction is that in October I had a radial and ulnar tunnel release in the same extremity. I wonder whether the medication has affected the nerves that had been manipulated during surgery. I am wondering if anyone participating gin the trial had recent surgery was well? if so, did they note any complication after receiving the vaccine. Any help you can give would be appreciated. Thanks you for your time.
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| 53 | 2021-01-16 | rash |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-17 | itchy skin |
Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed ...
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Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed to SOB, pruritis throat tickle TxT-ed self with Benadrl but symptoms persisted Went to ED txt with Bendryl, prednisone, zyrtec.
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| 53 | 2021-01-19 | rash |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | injection site pain | Headache, body aches, low grade fever (100.6), fatigue, injection site tenderness |
| 53 | 2021-01-19 | itchy skin, rash, hives |
Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Fa...
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Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Famotidine taken. Admitted to ED at 4 am on January 18, Prednisone given. Symptoms were improving and discharged at 7 am the same day. Hives and itching were worse and facial edema and rash noted on night of January 18. Treatments included Benadryl and Famotidine. Morning of January 19, 40 mg Prednisone and Benadryl every 4-6 hours. Morning of January 20, hives and rash and itching persists on stomach, legs, arms, and ears. 40 mg of Prednisone and Benadryl. (Present time - hives, rash, and itching still persists with less severity)
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| 53 | 2021-01-19 | injection site pain |
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection si...
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Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
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| 53 | 2021-01-19 | redness, itchy skin |
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The...
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Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
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| 53 | 2021-01-21 | injection site pain |
Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body ache...
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Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body aches all over body. Injection site pain as well. On 1/21/2021 at 0500 began having chills and running a fever of 102.4. The head ache subsided around 1800. The body aches and fever were gone by 0700 on 1/22/2021. At this point (1/22/2021 1450) just exhausted, but no other aches or pains. During the time of the head ache initially took Tylenol which did nothing. Then took a low dose of Ibuprofen which took an edge off.
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| 53 | 2021-01-24 | rash, tingling |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-24 | injection site redness, injection site warmth, injection site swelling, injection site mass |
My arm was red, swollen, hot to touch and swelled up about 1 inch around the injection site. I still...
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My arm was red, swollen, hot to touch and swelled up about 1 inch around the injection site. I still have about a pea size knot there. It doesn't bother me unless I bump that spot.
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| 53 | 2021-01-24 | injection site mass, injection site swelling, injection site redness |
VACCINE 1: SWELLING, REDNESS AT INJECTION SITE, KNOT UP TO APPROX 1 INCH DIAMETER ALL THE WAY AROUND...
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VACCINE 1: SWELLING, REDNESS AT INJECTION SITE, KNOT UP TO APPROX 1 INCH DIAMETER ALL THE WAY AROUND INJECTION (SITLL HAVE PEA SIZED KNOT AT INJECTION SITE) VACCINE 2: SWELING, REDNESS AT INJECTION SITE
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| 53 | 2021-01-24 | injection site warmth, injection site pain | pain at injection site- 24 hours warmth at injection site- 24 hours fatigue- 24 hours |
| 53 | 2021-01-25 | redness |
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi...
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Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
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| 53 | 2021-01-25 | hives, itchy skin, redness |
Experienced Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands Treated with D...
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Experienced Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline x 1000 ml
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| 53 | 2021-01-25 | itchy skin |
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches....
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Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
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| 53 | 2021-01-25 | hives, itchy skin, redness |
Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands. Treated with Diphenhydram...
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Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands. Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline IV solution x 1000 ml
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| 53 | 2021-01-26 | injection site pain |
Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left a...
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Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left arm. Whole body inflammatory response. Treatment: Ice, Tylenol and Hydrocodone. Called physicians office to inform. Awaiting call back if anything needs to be done.
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| 53 | 2021-01-26 | rash, tingling |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-28 | hives |
1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a s...
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1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a steriod shot (methylPREDISolone (Medrol (pak)) and I was given famotidine (Pepcid pill). A prescription was called into my pharmacy (famotidine and methylPREDNISolone)
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| 53 | 2021-01-28 | rash |
Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable...
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Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable other healthcare professional (hcp; patient for herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, HTN (hypertension), migraines, and blepharitis. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), metoprolol tartrate, lisinopril, colecalciferol (VIT D3), fish oil, and "mul" as reported. The first dose of BNT162B2 (brand Pfizer, lot EL1284) for COVID-19 immunization was administered on 22Dec2020 at 05:30 pm in the left arm. The patient had no other vaccines in four weeks. On 13Jan2021 08:45 pm, the patient experienced fever, joint pain left side, rash on legs and headache. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events fever, joint pain left side, rash on legs and headache were recovered on an unknown date in Jan2021.
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| 53 | 2021-01-28 | itchy skin |
feeling itchy from the inside; This is a spontaneous report from a contactable other HCP (patient). ...
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feeling itchy from the inside; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via an unspecified route of administration, on 11Jan2021 01:00 PM (at the age of 53 years old) as a single dose on left arm for COVID-19 immunisation at a hospital facility. Relevant medical history included High blood pressure, diabetes, known allergies: shellfish (onset dates unknown). Past drug history included known allergies: silva on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, the patient stated that for 3 to 4 days she has been feeling itchy from the inside. She is allergic to shellfish and the feeling she was having was similar to how she felt if she ate shellfish. She hadn't eaten anything out of the ordinary to make her felt this way. The patient received treatment for the event which included diphenhydramine (BENADRYL). The outcome of the event headache was not recovered. Information on the Lot/Batch number has been requested.
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| 53 | 2021-01-28 | injection site redness, injection site pain, injection site warmth | injection site warmth, pain and redness |
| 53 | 2021-02-08 | injection site pain |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-14 | tingling, redness, bruising |
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl...
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reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-21 | injection site swelling, injection site mass, injection site pain |
About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hour...
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About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.
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| 53 | 2021-02-22 | redness, itchy skin, hives |
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot...
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1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
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| 53 | 2021-02-22 | injection site pain |
2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and fre...
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2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 – Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 – Woke feeling tired but better. 2/22/21 – In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 – woke up feeling better.
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| 53 | 2021-02-24 | injection site pain |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-25 | vaccination site pain |
Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontane...
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Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontaneous report from a contactable consumer (patient). This 53-year-old non-pregnant female patient received the first dose of BNT12B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unknown route of administration in the left arm on 26Jan2021 (at the age of 53-years-old) at 3:30 PM as a single dose for COVID-19 immunization. The patient's medical history included hypertension and penicillin allergy, both from unknown dates and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) from an unknown date for an unknown indication; amlodipine from an unknown date for an unknown indication; fish oil from an unknown date for an unknown indication; and vitamin B complex (VITAMIN B 50) from an unknown date for an unknown indication. The patient previously took levofloxacin (LEVOQUIN) on an unknown date for an unknown indication and experienced allergies; and influenza vaccine on an unknown date for an unknown indication and experienced pain. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported experiencing left arm very sore up through left neck; not red just aching and pain through the first night post injection. The patient reported being still sore on day two; much more pain than flu shot previous experience. The event was reported as non-serious and did not require hospitalization. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The clinical outcomes of left arm very sore up through left neck were recovering. It was also reported the patient was not diagnosed with COVID-19 prior to vaccination and that the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-02-28 | injection site pain, injection site redness |
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin...
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First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
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| 53 | 2021-02-28 | rash |
Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that r...
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Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that reported for herself. A 53-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL8982 on 22JAN2021 15:00, as single dose (at the age of 53 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. There were no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 26Jan2021 at 06:00 the patient experienced Rash face and neck. The patient received treatment (Benadryl and aloe). The outcome rash face and neck are recovering. The case was reported as non-serious by the reporter.
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| 53 | 2021-02-28 | redness |
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in...
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Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-02-28 | vaccination site redness, vaccination site itchiness, vaccination site pain, vaccination site swelling |
swelling and soreness at the injection site; soreness at injection site; red, and a little swollen a...
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swelling and soreness at the injection site; soreness at injection site; red, and a little swollen at the injection site; felt itchy at the injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular on the right arm near shoulder on 19Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. There were no other vaccine received within 4 weeks prior to COVID vaccination. After she got a tetanus shot (probably needs another since it had been ten years) her arm/ muscle was sore. Patient had typical swelling and soreness at the injection site on Jan2021that went away within a couple of days and then did not have any symptoms. Then today all of a sudden it felt sore, red, and a little swollen at the injection site again. It has been more than a week since the symptoms initially resolved and now they have reemerged. It felt itchy at the injection site, it had a raised red area that was itchy on Jan2021. She did go running this morning and has been running several times, she went running the day after she got the vaccine. Events did not require emergency room nor a visit to the physician's office, and no treatment was given. Outcome of the events was unknown.
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| 53 | 2021-03-14 | vaccination site pain |
also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days...
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also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); mild pain/soreness at the site of injection evening and following day post vaccination; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (at the age of 53-years-old) on 27Jan2021 11:30 at a single dose in left arm for COVID-19 immunization. Medical history type 2 diabetes. Concomitant medication included metformin (METFORMIN), colecalciferol (VITAMIN D), omega-3 fatty acids (OMEGA-3 FATTY ACIDS), multivitamins with minerals [umbrella term] (CENTRUM) and ''tumeric". The patient previously took azithromycin and experienced drug allergies. The patient experienced mild pain/soreness at the site of injection evening and following day post vaccination, on 27Jan2021 23:00, also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently) on 28Jan2021. No treatment received for the adverse events. The outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 53 | 2021-03-17 | itchy skin |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-22 | tingling |
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT...
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FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
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| 53 | 2021-03-22 | skin spots, rash |
Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and ar...
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Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and arms, purpuric bruising on bottom lip, and mild nosebleeds x 2 days. Transferred on 3/11 to Hospital for lab work due to suspicion of idiopathic thrombocytopenic purpura, and found to have a platelet count <2. Treated with IVIG from 3/11 to 3/12. Platelets normalized by follow-up testing on 3/18, confirming the diagnosis of ITP.
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| 54 | 2020-12-31 | redness | Raised red area, that did not itch but became a circle of scabs |
| 54 | 2021-01-01 | injection site swelling, injection site redness, injection site pain |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-02 | tingling |
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a...
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Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
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| 54 | 2021-01-03 | injection site pain | Arm Pain at injection site - pleased to report nothing else. Thank you |
| 54 | 2021-01-03 | injection site pain |
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ...
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I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
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| 54 | 2021-01-03 | rash |
Received first dose of Pfizer vaccine on December 28th in left upper arm. On the afternoon of Decemb...
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Received first dose of Pfizer vaccine on December 28th in left upper arm. On the afternoon of December 30th a rash was identified on my torso. It was not very itchy, took few doses of Benadryl and was resolved next day. May I receive the second dose scheduled in few weeks?
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| 54 | 2021-01-03 | injection site pain |
got localized pain for a few days on my left arm from injection site, I developed malaise, headache...
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got localized pain for a few days on my left arm from injection site, I developed malaise, headache, a fever 101.8 the day after the injection, fever subsided that night. Headache went away the 2nd day of vaccination.
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| 54 | 2021-01-04 | hives, itchy skin |
Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 1...
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Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 17cmx28cm in size. Patches are erythematous, pruritic and appear to have a central clearing. Pt tried applying a topical anti-fungal cream initially, but it did not help. Also applied a regular topical emollient which also did not help.
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| 54 | 2021-01-04 | injection site nodule, bruising, redness |
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided...
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Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
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| 54 | 2021-01-04 | hives |
Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl ...
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Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.
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| 54 | 2021-01-04 | vaccination site pain |
Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (p...
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Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.
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| 54 | 2021-01-04 | hives |
hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous r...
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hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: ett9899, expiration date: unknown), intramuscularly on the left arm on 17Dec2020 at 10:45 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension, diabetes, tachycardia, diverticulitis, and known allergies to pimentos. Concomitant medications included metformin and metoprolol tartrate (LOPRESSOR). The patient previously took valaciclovir hydrochloride (VALTREX) and experienced allergies to it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hivers on lower back to side and left leg and joint stiffness over entire body on an unspecified date in Dec2020 with hive improvement several days later. The patient received diphenhydramine (BENADRYL) and paracetamol (TYLENOL) orally from the emergency room as treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as non-serious. The patient recovered from the events "hivers on lower back to side and left leg and joint stiffness over entire body" on an unspecified date in Dec2020.
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| 54 | 2021-01-05 | redness |
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel...
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20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
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| 54 | 2021-01-05 | tingling, injection site pruritus, rash macular, itchy skin |
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ...
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Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
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| 54 | 2021-01-05 | tingling |
I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon w...
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I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.
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| 54 | 2021-01-05 | itchy rash |
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA...
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PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
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| 54 | 2021-01-05 | itchy rash, rash |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-05 | injection site pain |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
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| 54 | 2021-01-06 | injection site pain |
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar...
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Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
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| 54 | 2021-01-06 | itchy rash |
Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded thr...
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Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded throughout arm. Started the same way on the other arm a few hours later. By the evening, the rash encompassed both arms and started at both ankles. After 24h, the rash was over all 4 extremities. Took benadryl (50mg once) without effect on rash.
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| 54 | 2021-01-06 | injection site pain |
pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint ...
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pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint pain ocular migraines (had aura 3 or 4 times that next week, this is something I do not experience frequently, hadn't had one for at least 15 years prior to the vaccine
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| 54 | 2021-01-07 | vaccination site pain |
Arm pain at injection site; This is a spontaneous report from a contactable other healthcare profess...
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Arm pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: unknown, unspecified route on 28DEC2020 12:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included ergocalciferol (VIT D), calcium (CALCIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 03:45, the patient experienced arm pain at injection site. The event arm pain at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event arm pain at injection site was recovered. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination = Nasal Swab, Covid test date on 30Dec2020 and result was negative. Information on lot/batch number has been requested.
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| 54 | 2021-01-07 | rash, itchy skin |
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati...
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At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
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| 54 | 2021-01-07 | vaccination site pain |
Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she...
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Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she received vaccine was getting sore and very heavy.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 04Jan2021 morning at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine this morning (04Jan2021) and complained arm where she received vaccine was getting sore and very heavy. The events took place after use of product. She took Tylenol and stated that she feels better. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-01-07 | vaccination site pain |
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p...
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Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
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| 54 | 2021-01-07 | vaccination site pain |
Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a sponta...
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Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
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| 54 | 2021-01-07 | injection site redness |
Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken...
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Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken to emergency department for evaluation.
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| 54 | 2021-01-07 | vaccination site pain |
Some muscle soreness around injection site. Started about 10 hours after injection and lasted about ...
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Some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours; This is a spontaneous report from a contactable other health care professional. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Dec2020 11:30 at single dose, at left arm for COVID-19 immunization. Medical history included arthritis. On 31Dec2020 21:30, it was reported that the patient experienced some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours. The patient did not receive treatment for the event. The outcome of the event was recovered. Information about lot/batch number has been requested.
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| 54 | 2021-01-07 | rash, itchy skin |
Starting on the second day after vaccine I started to get itchy, first my arms and back and eventual...
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Starting on the second day after vaccine I started to get itchy, first my arms and back and eventually all over. On the third day I started to see pumps on my itchy skin. I started to take benadryl 25mg on the 26th and 27th. Doubled the dose to 50mg at night time for 5 days. Took medicated baths and Sarna cream, along with benadryl cream. The symptoms started to subside. I took only benadryl 25mg on January 2nd and 3rd. Now I am still somewhat itchy but only using topical creams. I do have seasonal eczema and dry and itchy skin in the winter but this was definitely something more than my winter symptoms.
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| 54 | 2021-01-07 | vaccination site pain, vaccination site swelling |
Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling;...
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Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none. The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown Information on batch number has been requested.
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| 54 | 2021-01-07 | injection site pain |
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi...
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Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
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| 54 | 2021-01-07 | vaccination site pain |
arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shou...
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arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shoulders earlier; Neck is till sore, midline to posterior; This is a spontaneous report from a non-contactable nurse (patient herself that works at the surgical center of the hospital). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EX9231, expiry date: Apr2021), via an unspecified route of administration on 03Jan2021 at a single dose as Covid-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient received flu vaccine on 29Oct2020. On 03Jan2021, the nurse reported some arm pain (unspecified) following the injection and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day. On 03Jan2021, pain was bilateral shoulders earlier, now subsiding. Neck was till sore, midline to posterior. The event arm pain (unspecified) following the injection was recovered on 04Jan2021. The patient was recovering from shoulder and neck stiffness and "pain was bilateral shoulders earlier". The outcome of the event neck was till sore, midline to posterior was not recovered. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-01-07 | vaccination site swelling, vaccination site redness |
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c...
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dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
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| 54 | 2021-01-07 | tingling, rash |
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. ...
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right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
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| 54 | 2021-01-08 | tingling |
Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Deni...
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Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Denies any rash, mouth/throat swelling, difficulty breathing, itching, wheezing, or racing heart. Check vitals: O2 98% HR 72 BP 118/80 Monitored until 11:20. Rechecked periodically and her symptoms resolved. Advised that if symptoms return then go to ER. Discharged home.
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| 54 | 2021-01-09 | injection site pain |
I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperatur...
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I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperature, I went back to bed after taking Advil until I woke up at 2pm, then took Tylenol. By 4 pm I felt much better. My injection site was much more sore than the first dose.
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| 54 | 2021-01-09 | hives | Urticaria, treated with diphenhydramine, pepcid, prednisone. Improved. |
| 54 | 2021-01-10 | rash |
"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40...
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"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
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| 54 | 2021-01-10 | itchy rash, rash |
10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was ...
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10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.
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| 54 | 2021-01-10 | tingling |
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and...
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30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
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| 54 | 2021-01-10 | injection site pain |
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, pa...
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Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.
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| 54 | 2021-01-10 | injection site pain |
Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pai...
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Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pain at injection site which subsided after episode of rigors.
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| 54 | 2021-01-10 | injection site pain |
Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Sat...
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Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned. Hurt to move my head. Woke up on 1/10, extreme headache and nausea. Hurt to move head and was nauseated whenever I bent over.
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| 54 | 2021-01-11 | injection site pain |
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ...
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I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
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| 54 | 2021-01-11 | injection site pain |
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right...
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Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
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| 54 | 2021-01-11 | injection site rash |
employee received the first COVID vaccine in her left arm. The following morning she woke up with a...
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employee received the first COVID vaccine in her left arm. The following morning she woke up with a rash on her left arm that spread to her neck. She has been managing it with antihistamines, has not missed work and is contacting her PCP today
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| 54 | 2021-01-11 | pain of skin, injection site pain |
headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/3...
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headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/30 next morning - chills, muscle pains (sharp/fast) entire day 12/30 fatigue entire day 12/30 skin hurt (especially in shower, felt like water was burning my skin) entire day 12/30
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| 54 | 2021-01-11 | hives |
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma an...
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pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine
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| 54 | 2021-01-11 | rash |
rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable...
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rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
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| 54 | 2021-01-12 | shingles | I developed a severe case of Shingles. |
| 54 | 2021-01-12 | vaccination site swelling, vaccination site pain, vaccination site redness |
headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness an...
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headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness and swelling; Injections site pain; tiredness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via intramuscular on 05Jan2021 10:30 in left arm at single dose for covid-19 immunization. Medical history included hypothyroidism, arthritis, hypertension, eczema. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was known allergies: daptomycin and cefdinir (OMNICEF). The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included clonidine, levothyroxine sodium (SYNTHYROID), ibuprofen. The patient experienced injections site pain, tiredness, headache, muscle pain, chills, fever, injection site redness and swelling on 06Jan2021 11:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Events were reported as non-serious.
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| 54 | 2021-01-13 | injection site pain |
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,...
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Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-01-13 | injection site rash, injection site redness | Rash and redness around injection site Arm soreness Chills Fever |
| 54 | 2021-01-13 | injection site pain | Site pain; Shoulder pain |
| 54 | 2021-01-13 | hives | c/o dizziness, SOB, hives, "flushed" |
| 54 | 2021-01-13 | itchy skin |
itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened ...
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itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened and spread; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), intramuscular on 05Jan2021 10:30 at single dose on left upper arm as Covid vaccine. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient stated that she was inoculated on 05Jan2021 with the COVID-19 vaccine at 10:30 AM in left upper arm. On 07Jan2021 (this morning), she was having a side effect that was not listed on information provided to her. She was itching, moderate itching, no rash, mostly on torso and legs and has taken some hydroxyzine 50mg to see if that would help stop the issues. Patient had a call with PCP today as well, started on right leg and has worsened and spread. Patient works in human resources for one of the hospitals. which is why she was able to get the vaccine. Patient had no pain at injection site or any other issues. Outcome of the event was not recovered (reported as "itching was reported as worsened"; ongoing).
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| 54 | 2021-01-14 | tingling |
12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet...
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12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet to legs. I called office and put on prednisone for 3 days. Then another 7 days prescribed; 12/23rd 1st vaccine; The same day, I was having the tingling and pain came back after the shot. But I still had had from flu shot, it just came on stronger. It wasn't as bas as after the flu shot. Took another 10 days of prednisone. 1/13/2021 2nd vaccine; sore arm, little tired. But could be as I had to wake up early.
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| 54 | 2021-01-14 | hives | Hives within 2 hours and then onset of Tachycardia lasting 36 hours on and off. |
| 54 | 2021-01-14 | injection site redness, injection site swelling, rash |
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (oth...
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Increase in BP to 184/91; symptoms lasted 1 day
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| 54 | 2021-01-14 | injection site pain |
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as...
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Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
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| 54 | 2021-01-14 | hives, injection site pruritus, rash |
WITHIN MONITORING TIME PERIOD, PT. COMPLAINED OF INJECTION SITE ITCHINESS AND OVERALL BODY HIVES. ...
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WITHIN MONITORING TIME PERIOD, PT. COMPLAINED OF INJECTION SITE ITCHINESS AND OVERALL BODY HIVES. NO OTHER COMPLAINTS. EMS ON SITE.
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| 54 | 2021-01-16 | rash, shingles | painful rash. appears to be shingles |
| 54 | 2021-01-17 | itchy rash, rash papular |
Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulati...
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Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95. Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities. leg signifiant more populated than arms. Rash now on tops and bottoms of feet. Minimal spots on dorsal hands and none on palms. Extremely itchy. + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed. Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
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| 54 | 2021-01-19 | redness |
Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after re...
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Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after receiving vaccine.
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| 54 | 2021-01-19 | itchy skin | Facial itching 25mins after administration |
| 54 | 2021-01-19 | rash |
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ...
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Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
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| 54 | 2021-01-19 | injection site pain | Sore right arm where I received the shot. Swelling and soreness in my shoulder. Sore neck. |
| 54 | 2021-01-19 | injection site swelling | Swelling to armpit on side of injection, low grade fever persisting |
| 54 | 2021-01-21 | injection site pain |
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s...
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Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-21 | injection site pain | SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES |
| 54 | 2021-01-21 | tingling |
Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezin...
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Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezing, difficulty breathing. Transported to ER
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| 54 | 2021-01-21 | redness |
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk...
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Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
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| 54 | 2021-01-21 | itchy skin, redness | redness, swelling and slight itchiness to left arm |
| 54 | 2021-01-21 | injection site pain | temp 100.2-100.6/fever/chills, body aches, injection site L.arm very sore/heavy/painful |
| 54 | 2021-01-24 | injection site swelling, injection site pain |
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm...
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Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
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| 54 | 2021-01-24 | hardening | Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds |
| 54 | 2021-01-24 | injection site pain | Headache, Injection site pain, Tiredness, Joint pain, Chills |
| 54 | 2021-01-24 | tingling |
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ...
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Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
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| 54 | 2021-01-24 | itchy skin |
patient developed itching throughout her body approximately 25 minutes after administration. She was...
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patient developed itching throughout her body approximately 25 minutes after administration. She was observed for 15 minutes. No hives developed. This itching came and went
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| 54 | 2021-01-25 | injection site pain |
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid...
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I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
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| 54 | 2021-01-25 | vaccination site warmth, vaccination site pain, vaccination site redness |
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection ...
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axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter. Information on the Lot/Batch number has been requested.
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| 54 | 2021-01-25 | vaccination site pain |
fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactab...
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fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: El1283; expiration date: unknown), via an unspecified route of administration right arm on 12Jan2021 17:15 at SINGLE DOSE for covid-19 immunization. Medical history included diabetic, high blood pressure, high cholesterol, ADHD (attention deficit hyperactivity disorder), anxiety, depression and IBS (irritable bowel syndrome). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lovastatin (LOVASTAT), bupropion hydrochloride (BUPROPION HCL XL) and networking 750mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer Covid 19 vaccine in a hospital. The patient experienced fatigue, headache and muscle ache and injection pain site on 13Jan2021 06:00 PM (18:00). The patient did not received treatment for the adverse events. The events were reported as non-serious. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering.
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| 54 | 2021-01-26 | injection site redness, redness, injection site rash, injection site warmth |
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot....
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I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm hot spot on my chin and the left cheek saw red and hot.
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| 54 | 2021-01-26 | rash, redness |
I had a red hot rash on my face that lasted about a week. During the night, I woke to my face cover...
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I had a red hot rash on my face that lasted about a week. During the night, I woke to my face covered all over after being clear at bedtime.
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| 54 | 2021-01-26 | itchy skin |
I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower ...
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I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower part of my body. I took Tylenol every 6hrs. and zyrtec. It took 3 days, feeling better.
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| 54 | 2021-01-26 | injection site hardening, injection site redness, injection site swelling, injection site warmth |
I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling...
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I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling body aches and ran a low grade fever of 100 around 5:00 P.M. on 1/26/2021. The injection site has a lump about the size of a quarter, red and warm to the touch. I took two Tylenol at 9:30 P.M. on 1/26/2021 and went to bed. I awoke at 7:30 A.M. on 1/27/2021 feeling fine, but he injection site is still swollen, red and warm to the touch.
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| 54 | 2021-01-28 | vaccination site pain |
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle sor...
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her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
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| 54 | 2021-01-31 | tingling |
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalanc...
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Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.
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| 54 | 2021-02-01 | pain of skin |
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea...
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kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
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| 54 | 2021-02-02 | itchy skin, rash |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-04 | rash, itchy skin |
Developed rash on arms and front of legs with severe itching. She was placed on Medrol dose pack by ...
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Developed rash on arms and front of legs with severe itching. She was placed on Medrol dose pack by PCP then hospitalized 1/27/21-1/29/21.
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| 54 | 2021-02-04 | rash |
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight...
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bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
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| 54 | 2021-02-07 | tingling, injection site pain |
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE...
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next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
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| 54 | 2021-02-09 | skin spots, rash | Severe thrombocytopenia (Platelets = 5) and diffuse petechial rash to trunk and extremities |
| 54 | 2021-02-10 | skin spots |
Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 wee...
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Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 week after the 1st dose, patient said she developed a rash. On presentation on 2/10/21, the rash appeared to be petechial in nature. Prior to coming to the hospital, the patient had blood work done at her ALF and was told she had zero platelets and she was sent to the hospital. Admission labs at the hospital on 2/10 also showed zero platelets and immune thrombocytopenia is suspected.
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| 54 | 2021-02-10 | itchy rash |
dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a...
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dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-12 | rash, redness, cellulitis |
Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion ...
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Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.
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| 54 | 2021-02-21 | rash |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | rash |
Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bo...
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Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bones and then ankles over the course of a week. Prednisone was prescribed and helped.
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| 54 | 2021-02-21 | injection site pruritus, itchy skin |
Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin cen...
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Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin centralized on face starting Friday, February 19 around 5 PM. It continues. Benadryl 25 mg taken by mouth.
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| 54 | 2021-02-22 | tingling |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | rash macular, itchy skin |
C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential...
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C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential noted neck right clavicle area. Denies pain, SOB, dizziness, nausea. P76. Checked by EMT. EMT instruct ti take oral benadryl when she gets home. Client stated that perfums,perfume, lotions can set off itchy feeling when shesmells perfume.
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| 54 | 2021-02-23 | itchy skin, hives |
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at...
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Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
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| 54 | 2021-02-23 | itchy skin |
Waited 15 minutes as required and left. At 20-25 minutes as I was driving my mouth began to severely...
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Waited 15 minutes as required and left. At 20-25 minutes as I was driving my mouth began to severely itch. Arrived home, and took Benadryl which lessened the itch and it was almost gone by 2am on 2/24/2021.
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| 54 | 2021-02-25 | tingling |
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu...
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After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
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| 54 | 2021-03-09 | itchy skin, hives |
difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This...
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difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-03-13 | tingling, injection site swelling, injection site numbness, injection site tingling |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 55 | 2021-01-02 | hives, itchy skin |
25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itchin...
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25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.
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| 55 | 2021-01-03 | rash |
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi...
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Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
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| 55 | 2021-01-03 | injection site pruritus, itchy skin |
itching that started @injection site and then spread across body, facial flushing Administered 50 mg...
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itching that started @injection site and then spread across body, facial flushing Administered 50 mg of diphenhydramine orally and continued to observe Patient's husband was called and he took her home after approximately 30 mins.
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| 55 | 2021-01-04 | itchy rash, rash |
6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wris...
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6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists. I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not. I was advised to report it. It was bad enough to have been prescribed prednisone
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| 55 | 2021-01-04 | rash | Agitation, Sedation, Anaphylaxis, Rash & HYPOtension |
| 55 | 2021-01-04 | rash, itchy skin |
All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consume...
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All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, Lot: EL0140, Exp:Mar2021), via an unspecified route of administration on 21Dec2020 for first dose at single dose for COVID-19 immunisation. Medical history included blood pressure high and anxiety. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) for Blood pressure high and an anxiety medicine. The patient experienced itching there was nothing on 25Dec2020, in the morning of 26Dec2020, suddenly had rash all over back, butt, leg, she would like have the rash over body and she knew the reaction like the people like said it was within a couple of hours but this was more than couple of hours it is few days. At the time of reporting, no treatment received, she might go emergency to see if I get good dose of Benadryl. The event outcome was unknown.
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| 55 | 2021-01-04 | vaccination site pain |
fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontane...
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fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), intramuscular on the right arm on 26Dec2020 10:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), citalopram (CITALOPRAM), ascorbic acid (VITAMIN C), calcium (CALCIUM), loratadine (LORATADINE) and Sudaphrene pene (as reported). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 06:00 (as reported), the patient had fatigue, and some soreness at injection site. It was reported that the patient woke up on 27Dec2020 with 100.5 F that lasted most of day until 5 pm. It was mentioned that the patient did not receive any treatment for the events. The patient recovered from fever on 27Dec2020 17:00 while recovering for the remaining events.
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| 55 | 2021-01-04 | itchy skin |
itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health ...
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itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ELO140, via an unspecified route of administration in the arm left, first dose on 28Dec2020 16:15 at a single dose for Covid-19 immunization. Medical history was none, she had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to covid vaccine. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced a little itching on her left arm, face and neck, but other than that, nothing else, all on 28Dec2020 at 04:30 PM with outcome of recovered in Dec2020. No treatment received for the event.
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| 55 | 2021-01-05 | injection site redness, injection site warmth |
15 days post vaccine of the (Pfizer Covid vaccine) on 1/6, I developed a 7 x 5 cm erythematous whea...
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15 days post vaccine of the (Pfizer Covid vaccine) on 1/6, I developed a 7 x 5 cm erythematous wheal to left deltoid (injection site) - warm to touch without puritus/fevers or chills.
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| 55 | 2021-01-05 | itchy rash | Pruritic rash to dorsal hands. |
| 55 | 2021-01-05 | rash, itchy skin |
Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms...
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Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms.
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| 55 | 2021-01-05 | rash | Rash, chest pain, tachycardia, numb tongue, hard to swallow |
| 55 | 2021-01-05 | injection site mass, injection site redness | Temperature, cough, chest pressure, fatigue, redness and bump at immunization site |
| 55 | 2021-01-05 | rash |
Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor ...
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Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor took my blood pressure and it was fine, recommended Benadryl when I got home.
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| 55 | 2021-01-06 | shingles, rash |
Exactly one week after shot developed pain in back left flank. Over several days it moved to left si...
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Exactly one week after shot developed pain in back left flank. Over several days it moved to left side and front. One week later a rash developed. It is diagnosed as shingles. I?m now on Valtrex . I was also working night shift for several months which also may be the cause. I submit this because I?m not stressed. I don?t get sick. Maybe my immunity was suppressed by vaccine.
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| 55 | 2021-01-06 | injection site pain | INJECTION SITE PAIN, BREAST PAIN |
| 55 | 2021-01-06 | rash | Rash Narrative: |
| 55 | 2021-01-06 | injection site pain |
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ...
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Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
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| 55 | 2021-01-06 | redness, skin burning sensation, rash papular, rash, hives, itchy skin |
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ...
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Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
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| 55 | 2021-01-06 | injection site pruritus |
within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no s...
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within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no swelling or redness so we gave Benadryl 25mg and pt was fine afterwards. monitored after for 30 minutes with no issues
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| 55 | 2021-01-07 | injection site pain, injection site warmth, redness |
Erythema and edema in left arm area of administration. Warm and tender to touch and a mild hematoma ...
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Erythema and edema in left arm area of administration. Warm and tender to touch and a mild hematoma formed in the puncture site.
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| 55 | 2021-01-07 | vaccination site pain |
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain...
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Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
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| 55 | 2021-01-07 | hives, tingling |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | tingling |
Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then ...
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Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then to left hand and left arm. Benedryl PO 25mg given at 12:05pm. No changes after Benadryl given.
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| 55 | 2021-01-07 | hives |
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ...
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Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
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| 55 | 2021-01-07 | vaccination site pain, skin reaction, itchy skin |
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si...
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left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
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| 55 | 2021-01-07 | itchy skin, tingling |
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ...
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usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
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| 55 | 2021-01-07 | itchy skin |
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ...
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within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
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| 55 | 2021-01-08 | injection site redness, injection site swelling |
2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen ta...
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2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen taken
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| 55 | 2021-01-08 | injection site redness | 2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen |
| 55 | 2021-01-08 | injection site pain |
Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. ...
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Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.
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| 55 | 2021-01-08 | rash |
SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest an...
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SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.
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| 55 | 2021-01-09 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea...
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Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea & intense vomiting for several hours associated with severe chills and severe myalgia and severe arm pain (though no redness) at vaccine injection site. Vomiting/nausea continued despite Zofran x 2 and lasted ~ 8 hrs. The intense chills and myalgia lasted ~ 48 hrs- symptoms severe enough to keep me in bed for that time. Other than soreness at injection site and mild headache the next day, I had no adverse reaction after first vaccine dosage that was given on 12/21/20
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| 55 | 2021-01-10 | injection site redness, injection site warmth, injection site swelling, injection site pain, tingling |
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2...
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1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
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| 55 | 2021-01-10 | itchy skin, hives |
Received Vaccine Jan. 4, 2021 at 2pm. Starting "itching" at 7pm. Went to bed at 9pm and awoke Jan. ...
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Received Vaccine Jan. 4, 2021 at 2pm. Starting "itching" at 7pm. Went to bed at 9pm and awoke Jan. 5th (at 7am) with HIVES & ITCHING over upper chest, bilateral arms, upper back area and face. Took OTC Zyrtec 10 mg po and Pepcid 20 mg po. Went to work at 7pm. Took Prednisone 20 mg po at 2am. After working till 7am took Benadryl 25 mg po before going to bed at 8am Jan 6th. Symptoms relived by Wednesday evening.
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| 55 | 2021-01-10 | injection site swelling | Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site |
| 55 | 2021-01-10 | injection site warmth, injection site pain |
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du...
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lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
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| 55 | 2021-01-10 | injection site redness | localized redness at injection site, R arm/hand joint tenderness and pain, over 72 hr. period |
| 55 | 2021-01-11 | tingling |
Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later ...
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Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you
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| 55 | 2021-01-11 | skin infection at injection site |
Developed cellulitis at injection site. It should be noted that injection was to be given intramuscu...
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Developed cellulitis at injection site. It should be noted that injection was to be given intramuscularly but the RN who administered it gave to the back of the arm which was likely subcutaneous rather than intramuscular.
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| 55 | 2021-01-11 | rash, redness |
Employee had an allergic reaction after receiving the covid vaccine 2nd dose. She had rashes and red...
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Employee had an allergic reaction after receiving the covid vaccine 2nd dose. She had rashes and redness all over the body
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| 55 | 2021-01-11 | hives |
Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other hea...
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Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received the first dose of bnt162b2 (lot no. and expiry date unknown), intramuscular in left arm on 02Jan2021 16:15 at single dose for Covid-19 immunization. Medical history included mastocytosis. The patient is not pregnant. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jan2021 at 16:00, the patient experienced hives on stomach and chest 48 hours after. No treatment was received for the event. The outcome of the event was recovering. The event was assessed as non-serious. Information on the lot/batch number has been requested.
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| 55 | 2021-01-11 | rash, itchy skin |
Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old fema...
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Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-01-11 | rash, itchy skin |
Rash and itching on arms and legs; Rash and itching on arms and legs; This is a spontaneous report f...
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Rash and itching on arms and legs; Rash and itching on arms and legs; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), intramuscular, on 22Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The most recent COVID-19 vaccine was administered in a hospital. From 23Dec2020 to 27Dec2020, the patient experienced rash and itching on arms and legs. The patient took diphenhydramine hydrochloride (BENADRYL) to improve symptoms. The events were considered non-serious. The patient recovered from the events on 27Dec2020. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-12 | injection site pain |
Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth...
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Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth right after injection lasted 1 hour or so
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| 55 | 2021-01-12 | itchy skin | ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY |
| 55 | 2021-01-12 | itchy skin |
Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed...
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Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED. Upon arrival to ED, patient began to cough.
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| 55 | 2021-01-12 | injection site pain |
Post injection developed moderate to severe left arm pain - (when laying down unable to lay on that...
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Post injection developed moderate to severe left arm pain - (when laying down unable to lay on that arm for 3 days) then developed discomfort and stiffness in left shoulder, left elbow and left wrist that has continued but is slowly resolving. Spoke to Employee Health on 1/12/2021 and had virtual Employee Health consult on 1/13/2021. Treatment was to advised to take Ibuprofen/or Aleve. Discussed if should receive 2nd dose and was advised to receive by Health Care Provider.
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| 55 | 2021-01-12 | injection site pain, tingling |
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injec...
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The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
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| 55 | 2021-01-12 | tingling, rash |
to develop a rash yesterday. It started off as large red spots last night, and this morning they are...
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to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose. prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
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| 55 | 2021-01-13 | redness, hives, itchy skin |
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi...
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Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
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| 55 | 2021-01-13 | rash, itchy skin | Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles |
| 55 | 2021-01-13 | tingling, redness |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | rash |
I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full fron...
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I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
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| 55 | 2021-01-13 | itchy skin |
Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injecti...
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Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injection (left) and itchy in the mouth and numb in the tongue. Came to report to me (lead RPh for clinic) at 11:50am. I spoke with another staff member to get patient 50mg of benadryl. While I waited for the medicine, I inspected the patients arm, face and inside the mouth. No redness, swelling, hives or other signs/symptoms of allergic reaction. Arm looked normal, no discoloration. Same with face and inside mouth. Patient took 50mg Benadryl at 12pm. Patient also stated having sinus issues currently (before vaccination) and has had off/on reactions with flu shot and other vaccines, mainly itching in the arm that was injected and swelling at the injection site (grapefruit size). Patient reported feeling itchiness gone at 12:10pm but still having some numb tongue. By 12:23pm, patient reported feeling completely better and no more numbness in the tongue.
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| 55 | 2021-01-13 | rash, tingling |
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu...
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Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
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| 55 | 2021-01-14 | itchy skin |
36 Hours later I noticed that I was scratching my knuckles.. Very red and inflamed and tiny bumps ...
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36 Hours later I noticed that I was scratching my knuckles.. Very red and inflamed and tiny bumps .. One knuckles on left hand and two knuckles on my right hand
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| 55 | 2021-01-14 | tingling |
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee...
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About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
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| 55 | 2021-01-14 | shingles, blister |
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor...
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Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
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| 55 | 2021-01-14 | tingling |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | vaccination site pain |
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report...
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Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
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| 55 | 2021-01-14 | rash |
Patient received Covid vaccine dose #1 on 12/16/2021. Patient came to work on 12/17/2021 at 6:30am a...
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Patient received Covid vaccine dose #1 on 12/16/2021. Patient came to work on 12/17/2021 at 6:30am and noted rash on neck, left arm, legs, and back. Patient was given Benadryl, Claritin, and Solumedrol. Patient was admitted for 23 hours observation. Patient was discharged home on Claritin for 7 days.
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| 55 | 2021-01-14 | rash |
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r...
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Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
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| 55 | 2021-01-14 | injection site redness, injection site swelling, injection site bruising |
Red raised bruise on left arm at injection site not improving since onset of symptoms following vacc...
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Red raised bruise on left arm at injection site not improving since onset of symptoms following vaccination.
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| 55 | 2021-01-15 | injection site pain |
Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol fo...
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Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol for fever and aches
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| 55 | 2021-01-15 | injection site swelling, injection site pain |
Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 7...
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Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 72 hours
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| 55 | 2021-01-15 | itchy skin, rash |
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when...
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Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4. Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
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| 55 | 2021-01-15 | injection site swelling, injection site pain |
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig...
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Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
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| 55 | 2021-01-15 | injection site pain |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-16 | tingling |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-16 | rash macular, rash | Small, red, itchy blotches on my face, about 3/8? in diameter. |
| 55 | 2021-01-19 | tingling |
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ...
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I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
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| 55 | 2021-01-19 | injection site pain | Injection site soreness |
| 55 | 2021-01-19 | injection site bruising |
Pfizer vaccine was administered subcutaneously, rather than IM. No local reaction versus bruising a...
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Pfizer vaccine was administered subcutaneously, rather than IM. No local reaction versus bruising at site of injection and no post-vaccine systemic symptoms such as fever, HA, myalgias, etc.
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| 55 | 2021-01-21 | injection site pain |
1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SO...
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1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SORENESS AT INJECTION SITE. TOOK TYLENOL 7AM 1/20.
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| 55 | 2021-01-21 | itchy rash |
4 hours after receiving vaccine pt developed pruritic rash on arms and legs. Treated initially with ...
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4 hours after receiving vaccine pt developed pruritic rash on arms and legs. Treated initially with Claritin without relief so then took Benadryl. The following day the rash persisted so took Zyrtec. Also was prescribed triamcinolone cream. The rash resolved after the second day.
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| 55 | 2021-01-24 | injection site redness, injection site pain |
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik...
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I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
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| 55 | 2021-01-24 | sensitive skin, pain of skin |
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Th...
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The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
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| 55 | 2021-01-24 | injection site pruritus, itchy skin |
This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection si...
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This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection site. Today, 1/25, about 10 minutes after shot my eyes, face and neck began to itch. Developed small bumps. This continued to spread to armature torso and legs. Took Benadryl which seems to be helping. No difficulty breathing or swelling of any kind.
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| 55 | 2021-01-25 | injection site pain | Muscle - body aches, bad headache, lower back pain, tired arm shot area pain |
| 55 | 2021-01-25 | hives, blister, itchy skin |
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun...
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When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
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| 55 | 2021-01-26 | tingling |
About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sens...
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About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sensation, as if it were 'asleep'. Sensation not relieved by anything, not worsened by anything. Patient said it was more a nuisance than anything. Advised by clinic staff that might be nerve issue related to the injection itself. She said she would not want to go to the ER but would follow up with her primary care doctor if issue persisted.
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| 55 | 2021-01-26 | itchy skin | Itchiness in left arm (opposite of vaccine site). |
| 55 | 2021-01-26 | vaccination site pain |
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ...
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frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
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| 55 | 2021-01-26 | injection site pain, injection site hardening |
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w...
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had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
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| 55 | 2021-01-28 | skin burning sensation |
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ...
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Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
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| 55 | 2021-01-28 | rash, itchy rash |
Maculopapular pruritc rash on bilateral arms, chest, and back-improving 1/29/21 only with rash on ar...
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Maculopapular pruritc rash on bilateral arms, chest, and back-improving 1/29/21 only with rash on arms-prescribed Zyrtec and Clobetasol cream She is recovering but 100% back to noraml
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| 55 | 2021-01-28 | injection site rash, skin spots |
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Sat...
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Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
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| 55 | 2021-01-28 | redness, itchy skin |
Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed f...
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Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
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| 55 | 2021-01-31 | injection site rash, rash |
Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site. ...
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Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site. This rash continued to spread to entire body surface. Two doses of Benadryl 25mg were given then 911 was called to transport patient to local hospital for further evaluation
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| 55 | 2021-02-03 | injection site warmth, injection site pruritus, redness, itchy skin, itchy rash, injection site rash |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-04 | skin spots, injection site reaction, injection site rash |
petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ...
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petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events
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| 55 | 2021-02-07 | tingling |
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it wa...
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I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
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| 55 | 2021-02-21 | itchy skin |
Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer ...
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Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 55 | 2021-02-21 | tingling |
Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wr...
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Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.
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| 55 | 2021-02-22 | injection site pain |
Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? ...
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Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? Patient experiencing ha, and pain at injection site. Patient states it is getting better, but still voiced her concerns. Education provided of side effects vs illness and side effects lasting 7 days, follow up with PCP Dr. for further advice, and if patient continues to have symptoms after 7 days, phone EHS back for further evaluation. Patient agrees to above plan of care. EHS filled out RL6 for pt.
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| 55 | 2021-02-23 | injection site swelling, injection site redness, injection site pain |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
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| 55 | 2021-02-23 | injection site pain, itchy skin |
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me...
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Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
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| 55 | 2021-02-28 | vaccination site pain |
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l...
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sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
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| 55 | 2021-03-01 | injection site pain |
Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm p...
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Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.
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| 55 | 2021-03-02 | cellulitis |
cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare prof...
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cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-06 | tingling | Feet and leg hands arms back. Pins and needles numb |
| 55 | 2021-03-16 | swelling, hives |
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v...
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4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
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| 55 | 2021-04-07 | tingling |
Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient co...
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Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient complained uncomfortable numbness tingling in her arms and legs on 4/3. Was admitted to medical center on 4/5.
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| 55 | 2021-04-07 | tingling |
Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started a...
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Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.
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| 56 | 2020-12-31 | injection site pain, injection site reaction |
upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset...
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upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset stomach started around 11:00am & went away after having bowel movement, it returned again around 2:00pm & again went away after bowel movement, it returned for a third time around 3:00pm & that is when the diarrhea occurred. That was the last time of any signs or symptoms. I drank 2 cups of ginger tea afterwards which seem to help settle my stomach. The muscle pain, soreness & stiffness in left arm at injection site started at bedtime around 9:00pm on the day of receiving vaccine & still continues today but is improving
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| 56 | 2021-01-01 | injection site pruritus |
advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned a...
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advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned approx 20 min c/o itching to arm at injection site, stated, throat had been internally itchy for about 10 min after leaving vaccination area but that passed on its own. advised to use cold compress on arm and monitor self. let vaccination center without questions, concerns.
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| 56 | 2021-01-02 | hives | SEVERE HIVES FROM HEAD TO TOE LASTING APPROXIMATELY 21 HOURS I TOOK BENADRYL MULTIPLE DOSES |
| 56 | 2021-01-03 | injection site swelling, injection site pain |
12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is...
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12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol. This has continued beyond 72 hours.
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| 56 | 2021-01-03 | injection site redness, injection site warmth |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-03 | injection site pain, pain of skin | Headache Chills Temp (101.6) Body aches Skin hurts to touch Soreness in arm (injection site) |
| 56 | 2021-01-03 | injection site swelling, injection site pain |
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ...
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Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
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| 56 | 2021-01-03 | itchy skin, redness |
MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSE...
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MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSERVED AND RELEASE BUT RETURNED AT 15:21 WITH C/O ITCHING TO LOWER LEFT ARM. REDNESS NOTED IN THE SIZE OF ABOUT A HALF DOLLAR ON LOWER LEFT ARM.THIS NURSE ADMINISTERED 25MG OF PO DIPHENHYDRAMINE. PATIENTS VITIALS TAKE AND ADDITIIONAL OBSERVATION. PATIENT DID REPORT A HISTORY OF ALLERGIES TO COCONUT AND ASA ON CONSENT FOR (HIVES). PATIENT WAS LET WITH SUPERVISING NURSE FROM WORK. I CALLED TO CHECK ON PATIENT THE NEXT DAY AND PATIENT REPORTED THAT SHE WAS DOING FINE. PFIZERBIONTECH COVID-10 VACCINE EUA
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| 56 | 2021-01-03 | rash |
Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest to back over 3 days Mild a...
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Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest to back over 3 days Mild and improving in some areas as progressed to new areas by 1/4/2021 No fever, sore throat, cough, loss of taste or smell
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| 56 | 2021-01-03 | injection site pain |
Patient stated to this nurse @ 1100. Stated she had pain @ injection site to L arm. States that, "...
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Patient stated to this nurse @ 1100. Stated she had pain @ injection site to L arm. States that, "the needle went in to deep and touched her bone".
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| 56 | 2021-01-03 | tingling |
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,...
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Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
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| 56 | 2021-01-04 | itchy skin |
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I...
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About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
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| 56 | 2021-01-04 | shingles |
Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient...
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Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as "Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer". Patient was diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as "Started day after shot. Aching all over headaches. Broke out in shingles 7 days later". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 56 | 2021-01-04 | rash |
Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...lo...
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Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...looks like a contact dermatitis. Left wrist Topicals not helping. Wears a watch on that wrist, but not that day.
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| 56 | 2021-01-04 | vaccination site pain |
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel righ...
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Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
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| 56 | 2021-01-04 | tingling |
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he...
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Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
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| 56 | 2021-01-04 | rash, rash papular |
Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very...
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Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very small amount on back maybe 3-4 bumps
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| 56 | 2021-01-05 | rash |
Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade ...
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Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
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| 56 | 2021-01-05 | rash, skin spots |
Petechial rash which developed 3 days post vaccination on bilateral lower extremities. No respirator...
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Petechial rash which developed 3 days post vaccination on bilateral lower extremities. No respiratory distress. No changes in medications or diet habits. Feels weel
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| 56 | 2021-01-05 | vaccination site pain |
Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees...
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Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees; The arm pain was not your typical injection site pain from a flu shot; This is a spontaneous report from contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 25Dec2020 at 09:00 as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, arthritis, and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D) and losartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Dec2020 at 21:00, the patient experienced severe left side knee and shoulder pain, could barely walk, and could not lift left arm above 90 degrees. The patient stated that the arm pain was not your typical injection site pain from a flu shot. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcomes of severe left side knee and shoulder pain, could barely walk, could not lift left arm above 90 degrees, and arm pain was not your typical injection site pain of flu shot, were recovering. The events were all reported as non-serious. However, it was also reported that the duration of hospitalization was 1 (not further specified).
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| 56 | 2021-01-06 | rash macular | "Hot, Blotchy" given Benadryl 25mg liquid, po x1 dose. Resolved |
| 56 | 2021-01-06 | rash | Fever, body aches, and body rash on Day 2 |
| 56 | 2021-01-06 | itchy skin | Fever, chills, fatigue, itching |
| 56 | 2021-01-06 | rash, tingling | Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body |
| 56 | 2021-01-06 | rash, tingling |
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites...
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Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
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| 56 | 2021-01-06 | injection site pain, injection site hardening, injection site redness | Pain on injection site, turned red, swollen & hard. |
| 56 | 2021-01-06 | redness, itchy skin |
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ...
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Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
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| 56 | 2021-01-06 | injection site numbness, vaccination site pain |
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/...
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Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | redness, rash, itchy skin | Rash, itching, facial flushing/redness |
| 56 | 2021-01-06 | rash | SkinRash, CoughWheeze & Syncope |
| 56 | 2021-01-06 | itchy skin |
Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red la...
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Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .
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| 56 | 2021-01-06 | rash, tingling | headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body |
| 56 | 2021-01-06 | itchy skin, rash | rash on my upper thighs; left more inflamed than the right. Eventually went away. Ittchy. |
| 56 | 2021-01-07 | skin infection at injection site | Fatigue, body aches, cellulitis at injection site |
| 56 | 2021-01-07 | injection site pain | Fever 102.9, chills, body aches, pain at injection site, nausea, cough |
| 56 | 2021-01-07 | itchy skin, redness |
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG...
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HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
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| 56 | 2021-01-07 | injection site pain | Sore arm at injection site |
| 56 | 2021-01-07 | redness, itchy skin |
itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This ...
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itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899) intramuscular in the left arm on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hives and allergy to coconut and acetylsalicylic acid (ASA). Concomitant medications were not reported. The patient had been observed and released but she returned at 15:21 on 29Dec2020 with itching to lower left arm and redness was noted in the size of about a half dollar on lower left arm. Corrective treatment taken as a result of the events included 25mg of diphenhydramine orally. Patients vitals were taken (results unknown) and additional observation was done. The patient was left with supervising nurse. The patient was called the following day, 30Dec2020, and she reported that she was doing fine; she recovered from the events on 30Dec2020.
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| 56 | 2021-01-08 | itchy skin |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-08 | injection site pain | Headache, Myalgia, Arthralgia, fatigue, injection site pain Narrative: |
| 56 | 2021-01-08 | injection site pain |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-09 | injection site pain |
1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tyle...
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1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tylenol the morning after 2.) elevated skin temperature at night documented as 3 degrees above baseline by Fitbit Sense 3.) headache felt 26 hours after vaccine administration; 101.7 degree temperature documented 26 hours after vaccine administration since Tylenol 500 mg taken in the morning 4.) symptoms resolved the next day
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| 56 | 2021-01-09 | injection site pain |
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately...
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Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
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| 56 | 2021-01-09 | injection site hardening, injection site swelling, injection site pain, injection site reaction |
Raised, painful, erythematous and indurated injection site area with local increase in temperatur...
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Raised, painful, erythematous and indurated injection site area with local increase in temperature, compatible with Arthus Reaction at injection site.
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| 56 | 2021-01-09 | tingling | Sore arm and tingling in fingers |
| 56 | 2021-01-10 | injection site redness, itchy skin, injection site mass |
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel...
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01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
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| 56 | 2021-01-10 | redness |
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic...
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10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
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| 56 | 2021-01-10 | rash | Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion |
| 56 | 2021-01-10 | injection site redness, injection site warmth | Fever, chills, body aches, injection area red and warm to touch started the next day |
| 56 | 2021-01-10 | injection site redness, injection site pain | Fever, headache, chest wall soreness, muscle and joint pains, and site of injection redness and pain |
| 56 | 2021-01-10 | rash | My face broke out in a mild rash in the morning and progressed to my mid back and a few on my arm. |
| 56 | 2021-01-10 | injection site redness |
fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symp...
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fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.
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| 56 | 2021-01-11 | tingling |
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ...
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Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
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| 56 | 2021-01-11 | tingling |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | tingling |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-11 | itchy skin, rash, tingling |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | injection site pain |
Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She sta...
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Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She stated she developed increased pain in her right shoulder joint and was unable to sleep the night of the injection on 12/22/20. She stated the pain continued to increase and was unable to sleep on that shoulder. She was seen by her primary care provider on 1/8/21 for continued pain and decreased range of motion in her R shoulder, she is unable to raise it above shoulder height. She continues to have pain and decreased range of motion despite rest and ibuprofen.
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| 56 | 2021-01-11 | rash |
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine dif...
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Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling. The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
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| 56 | 2021-01-11 | vaccination site redness |
injection site was really red. It was the size of a 50 cent piece if not bigger; This is a spontaneo...
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injection site was really red. It was the size of a 50 cent piece if not bigger; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# 037K20A, expiration date: Jul2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose for Covid-19 immunisation. Medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO), warfarin and another medication. The patient worked in health care. She received the Covid-19 injection. The injection site was really red on 06Jan2021. It was the size of a 50 cent piece if not bigger. She wasn't sure if she should be worried. The outcome of event was not recovered.
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| 56 | 2021-01-12 | sensitive skin |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | rash |
Evening after second dose of Pfizer sars-cov2 vaccine she developed a painful vesicular rash on her ...
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Evening after second dose of Pfizer sars-cov2 vaccine she developed a painful vesicular rash on her face consistent with shingles. She does have a fair amount of stress in her life and it could have been unrelated but figured I should report anyway.
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| 56 | 2021-01-12 | injection site pain, injection site swelling |
Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and...
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Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and sinus congestion.
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| 56 | 2021-01-12 | injection site pain |
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw...
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Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
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| 56 | 2021-01-12 | injection site pain, injection site redness, injection site warmth, injection site swelling |
Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up v...
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Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up very lethargic ; as day went on had severe fatigue. About six pm strike fever; headache and fatigue (fatigue was the worst). Muscle aches started on the 10th and through the 11th. Next day (11th) no more fever; still fatigue but not as bad (moderate). By 11th in evening was feeling better that night. But still did not feeling well at all. On 12th - joint pain on 12th; and swelling and redness and it had heat and some pain on injection site (maybe had before but I didn't notice before). Took advil through all of this. Still have a mild headache off and on and today as well. And feeling fatigue now, too. No longer taking Advil.
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| 56 | 2021-01-12 | injection site pain |
significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours lat...
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significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours later fatigued in general not well-being, chills, fatigue, injection site pain, malaise new or worsened join and muscle pain
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| 56 | 2021-01-13 | injection site tingling, injection site numbness |
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t...
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"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
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| 56 | 2021-01-13 | tingling |
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine....
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56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
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| 56 | 2021-01-13 | vaccination site pain |
ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, m...
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ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 56 | 2021-01-13 | injection site pruritus, injection site pain, injection site swelling | PAIN INJECION AREA, SWELLING INJECTION AREA,INCHING. |
| 56 | 2021-01-13 | redness |
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT...
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PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
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| 56 | 2021-01-13 | injection site pain |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | rash, itchy skin, vaccination site itchiness |
itching/itching at the site and on her chest going all the way to her groin; rashes/She does have th...
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itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.
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| 56 | 2021-01-13 | vaccination site pain |
soreness at injection site by the end of day; This is a spontaneous report from a non-contactable ot...
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soreness at injection site by the end of day; This is a spontaneous report from a non-contactable other HCP (patient). This 56 year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date were not reported) on 05Jan2021 15:00 (at the age of 56-years) as single dose, unspecified route, left arm for COVID-19 immunisation. Medical history included known allergy to latex, wheat intolerance, and seasonal allergies, and hypothyroidism. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine (LEVOTHYROXINE), colecalciferol (VIT D3), ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT) and zinc (ZINC). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 05Jan2021 at 21:00 AM the patient experienced soreness at injection site by the end of day. The patient did not received treatment as a result of the event. The outcome of soreness at injection site by the end of day was recovered with sequele. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-01-14 | vaccination site pain |
Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable health...
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Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 56 | 2021-01-14 | tingling |
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left...
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Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
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| 56 | 2021-01-14 | vaccination site itchiness, vaccination site redness, vaccination site pain |
Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injec...
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Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021. The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.
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| 56 | 2021-01-14 | vaccination site pain |
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
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| 56 | 2021-01-14 | hives |
Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives ...
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Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives started on 1/11/21. Symptoms improved with Zofran, Pepcid and Benadryl. Symptoms resolved on 1/15/21. Patient had a history of COVID 19 virus infection in October 2020.
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| 56 | 2021-01-14 | vaccination site pain |
sore/pain injection site; This is a spontaneous report from a contactable nurse (patient herself). A...
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sore/pain injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm) on 17Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. The patient previously received bactroban ointment and experienced allergies. Patient is a registered nurse working in a small, rural hospital. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced sore/pain injection site. Outcome of the event was unknown. The patient has not been tested for COVID-19 since vaccination.
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| 56 | 2021-01-15 | itchy skin | tingling in jaw and neck, under ear. BP 130/68 |
| 56 | 2021-01-16 | rash |
12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities....
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12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities. Lasted until 12/22/2020. Nausea. called clinic on 12/21/2020 to report the rash. I tend to get rashes with different aspirin, cough medication, etc. PCP advised to take benadryl if happens again to control rash if occurs. I did take as the rash came back, took for one day, and the rash was gone the next day. 2nd vaccine EL3246
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| 56 | 2021-01-16 | rash |
12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called cli...
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12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called clinic that tuesday to report. Advised to take benadryl 2nd shot for rash. EL3246. Rash did occur. Went away after one day.
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| 56 | 2021-01-16 | itchy rash, rash, skin spots, rash papular |
About 10 days following the vaccine, developed an itchy, slightly painful, papular and petechial ra...
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About 10 days following the vaccine, developed an itchy, slightly painful, papular and petechial rash, primarily in underarms, arms, and legs. Antihistamine helped reduce symptoms. Rash has persisted, but improving.
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| 56 | 2021-01-16 | bruising |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-18 | hives, itchy skin | itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache. |
| 56 | 2021-01-19 | injection site pain |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | itchy skin | Bitter taste and itching (General) Received Benadryl 50 mg and improved |
| 56 | 2021-01-19 | injection site pain |
From the evening of the day I have received the vaccination, my left arm started to feel dull contin...
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From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
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| 56 | 2021-01-19 | tingling |
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ...
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Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
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| 56 | 2021-01-19 | itchy skin, redness |
Itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional i...
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Itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional intervention
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| 56 | 2021-01-19 | redness, itchy skin |
My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am l...
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My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure. The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl? The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
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| 56 | 2021-01-19 | tingling | PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE |
| 56 | 2021-01-19 | injection site redness |
Patient reports that the day after receiving the vaccine, she had a reddened area around the site. T...
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Patient reports that the day after receiving the vaccine, she had a reddened area around the site. The following day, she began having blisters and redness, near where the vaccine had been given. She reports she had taken Benadryl and Aleve, and the next day the the redness was half the size. Today, that area is intact, but shows white scaring.
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| 56 | 2021-01-19 | tingling | Patient reports tingling in hands, nausea, and sweating with the first dose. |
| 56 | 2021-01-19 | injection site pain | Reaction site pain and muscle aches |
| 56 | 2021-01-19 | injection site pain | fever extensive muscle and bone pains headache soreness at injection site lack of appetite chills |
| 56 | 2021-01-19 | hives, itchy skin, tingling | had itching and tingling the next day. with in 2 days hives all over chest and arms. |
| 56 | 2021-01-19 | itchy skin, redness |
itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional i...
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itchy sensation to arms, redness to chest. Rapid response called, patient monitored. No additional intervention
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| 56 | 2021-01-21 | hives | EVENING THAT VACCINE WAS GIVEN HIVES BROKE OUT ON BACK AND NECK , RESOLVED WITH BENADRLY. |
| 56 | 2021-01-21 | injection site swelling, injection site reaction, injection site warmth |
Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection....
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Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection. Arm increasingly red, inflamed and hot to touch at 72 hours post injection.
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| 56 | 2021-01-21 | itchy skin |
Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and...
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Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and itching. I took Benadryl to help control symptoms.
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| 56 | 2021-01-24 | redness, bruising, itchy skin |
Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled....
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Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled. Next morning it was pink and still itched but not as bad. I took pictures. The following evening I also took pictures. By then it was a dark red, looked like a bruise and followed the shape of my vein.
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| 56 | 2021-01-24 | rash, rash papular |
Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a s...
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Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3248), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient stated, "I got my first dose yesterday at 4:30 and then everything was fine and then at about 10:30 that night, I got a systemic rash all over my back, my chest, my stomach and my thighs and there were some spots on my arms and my legs. So, I went ahead and had took some Benadryl and I just monitored the rash and made sure it wasn't going to my face, or my eyes or my throat. I never had any difficulty in breathing or anything but it definitely was a reaction to something that was in the vaccine." Treatment: Consumer stated, "I took Benadryl last night. It was a capsule, 25 mg. Indication: Consumer stated, "I work at a hospital and right now the hospital that I work at is not requiring that we get it but they just advised that we should. But they left it to us if we want to get it or not and they said that they just have the first doses available." The outcome of the events was unknown.
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| 56 | 2021-01-24 | vaccination site itchiness, vaccination site redness, vaccination site swelling |
had a knot on her arm where the shot was administered; where the shot was administered that was itch...
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had a knot on her arm where the shot was administered; where the shot was administered that was itching; where the shot was administered that was redness; where the shot was administered that was swelling; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on left arm, via unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included she was exposed to Covid from a patient she was working with that came back positive on 05Jan2021 which exposed to Covid was prior to taking the shot. Concomitant medications were reported as none. Reporter stated that she came in last week and took Pfizer shot. Stated before the shot that she was exposed to Covid from a patient she was working with that came back positive. Wanted to know if she took Covid test would it come back positive automatically. Wanted to know if she was allowed to take the Covid test. She had on all of her PPE gear and N95 mask. She screened the patient but the patient had a mask on, she worked in dental, for a time period he that the patient had his mask off for a short time period. Stated that this was for the Pfizer Covid 19 shot, it was her first shot and she would take the second shot on 26Jan. Reporter was a dental assistant and calling on behalf of herself. Stated that she had a knot on her arm where the shot was administered that was swelling, red and itching on 06Jan2021. Stated that the knot was almost not there. Later stated that the knot was gone Saturday 09Jan. The outcome of event "where the shot was administered that was itching" was resolving while outcome of other events were resolved on 09Jan2021. Information about lot/batch number has been requested.
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| 56 | 2021-01-24 | tingling |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-25 | vaccination site pain |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-26 | redness |
High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sor...
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High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sore arm, ROM affected.
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| 56 | 2021-01-26 | rash, skin spots |
Outbreak started on upper extremities and some on abdomen; Petechial rash; This is a spontaneous rep...
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Outbreak started on upper extremities and some on abdomen; Petechial rash; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscular in right arm on 29Dec2020 10:30 at single dose for COVID-19 immunisation. The patient was not pregnant. The patient received vaccine in hospital. Medical history included rheumatoid arthritis (RA), hypertension. The patient didn't have known allergies. Concomitant medication included infliximab (INFLECTRA), leflunomide (ARAVA), meloxicam, acetylsalicylic acid (ASA), hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ), amlodipine besilate (NORVASC), cetirizine hydrochloride (WAL ZYR), multivitamin, biotin, collagen, cyanocobalamin (B12), echinacea. No other vaccine was received in four weeks. The patient had no COVID prior vaccination. Nasal swab was tested post vaccination on 05Jan2021 and result was negative. The patient experienced petechial rash on 01Jan2021 05:45 PM. On 05Jan2021 it started pinpoint barely noticeable. It rapidly spread till 05Jan2021, the patient took high dose steroids till Saturday 09Jan2021. On 09Jan2021 outbreak started on upper extremities and some on abdomen. The treatment for events included prednisone, diphenhydramine (BENADRYL) and acetaminophen (TYLENOL). The events resulted in emergency room visit and physician office visit. The outcome of events was recovering.
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| 56 | 2021-01-26 | injection site pain |
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ...
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headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-27 | redness |
Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report fro...
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Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
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| 56 | 2021-01-27 | redness, rash |
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ...
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On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
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| 56 | 2021-01-28 | redness |
10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema de...
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10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema developing on her chest.
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| 56 | 2021-01-28 | tingling |
CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any di...
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CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any difficulty breathing or any rashes/hives. Pt felt better after 30 mins and was cleared to RTW.
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| 56 | 2021-01-28 | tingling |
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ...
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close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-28 | itchy skin, redness, hives |
redness on her arm that extended to her elbow and up to her ear; She stated that she has a lot aller...
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redness on her arm that extended to her elbow and up to her ear; She stated that she has a lot allergies; stated that they were like hives and it was a little raised/bumps below her ear and below her jaw line now; said that her arm was itching by the time she got to her car; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3246; expiry date: unknown) intramuscular injection in the left arm, on 15Jan2021 at 10:20, for COVID-19 prophylaxis. Medical history included diabetic (type 2, insulin controlled, sugars are controlled, diagnosed about 1.5 years ago), allergies to Bee stings (needs EpiPen (hornets, yellow jackets) and a trip to the hospital) and anaphylactic allergy to tomatoes. Patient has no concomitant medications. The patient previously received flu vaccine that is allergen free. She said that she had a reaction to the regular flu vaccine about 10 years ago. She went to The ER and had severe hives, but no breathing issues, just a localized hive reaction. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient has no previous immunization with the Pfizer vaccine. The patient stated that she had her first dose of the Covid-19 vaccine today 15Jan2021. She said that about a half hour to 45 minutes after receiving the injection she had real redness on her arm that went down to her elbow and up to her ear and stated that they were like hives and it was a little raised. She said that she has bumps below her ear and below her jaw line now. She stated that she has a lot of allergies. She treated her symptoms with Benadryl. She also took Benadryl as a premed prior to getting the vaccination. She said that she called her allergist and sent her pictures of what was happening, and her allergist told her to take another Benadryl and to lay down and relax. She was a little worked up. The redness is not as red, but it is still warm, and it is still "raise" a tiny bit. The area on her arm is now about the size of a CD and doesn't extend to the elbow anymore. She said that she got the injection at 1020 and had to wait until 40minutes. Her arm was itching by the time she got to her car and she put an ice pack on it that she keeps for emergencies in her car. She took her second dose of Benadryl at 1300. She said that she probably slept until 1530 and noticed it was looking a little bit better. She was told that people have reactions like these, and it was not a big deal and she notified her doctor and occupational health. Outcome of the event redness was recovering, while for the other events was unknown.
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| 56 | 2021-02-01 | rash, shingles |
Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spo...
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Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none. Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time. She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
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| 56 | 2021-02-01 | redness, itchy skin |
extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by ...
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extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
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| 56 | 2021-02-01 | itchy skin |
severe itching; had some different allergies; This is a spontaneous report from a contactable nurse ...
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severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events "reaction to it, she had some different allergies and she got severe itching" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-01 | injection site pain |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-04 | injection site pain |
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site...
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chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-05 | itchy skin |
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon...
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56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
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| 56 | 2021-02-07 | itchy skin, redness |
itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacis...
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itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacist. A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL1284, intramuscular in left arm, on 21Dec2020 at12:30 ( at the age of 56 years old) as a single dose for COVID-19 immunization. Medical history included asthma, hyperlipidemia, PTSD, and seasonal allergies. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (rash), ciprofloxacin, codeine (vomiting, rash), escitalopram (dizziness, rapid heart rate). Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a hospital. There were no other vaccines within four weeks prior to the vaccination. On 21Dec2020 at 12:30, the patient experienced itchy sensation to arms, redness to chest. Rapid response was called, patient monitored. No additional intervention, no treatment provided. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination.
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| 56 | 2021-02-07 | hives, itchy skin |
my lips and tongue started itching and got swollen; my lips and tongue started itching and got swoll...
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my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-08 | injection site pruritus |
at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient instur...
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at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient insturected to "take a deep breath". She had her own benadryl and took it. Given epinephrine at 8:50 AM. BP was 140/84 and pulse was 64. At 8:55 patient reported relief from hard to breathe. Ambulance arrived at 9:00 AM.
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| 56 | 2021-02-11 | itchy skin |
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1...
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Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
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| 56 | 2021-02-14 | swelling |
Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side...
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Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-22 | blister | "Blister" |
| 56 | 2021-02-22 | itchy skin |
Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at...
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Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at ER and was discharged after an hours observation.
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| 56 | 2021-02-22 | tingling |
Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, includ...
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Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, including during the night but it comes and goes. Both hands have the tingling finger tips.
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| 56 | 2021-02-23 | skin burning sensation, rash, redness, itchy skin |
They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I w...
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They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.
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| 56 | 2021-02-23 | vaccination site pain |
severe soreness at the injection site; soreness at the injection site was so severe that she was una...
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severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-02-23 | vaccination site pain |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-24 | vaccination site swelling, vaccination site itchiness, vaccination site redness |
Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a...
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Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 05Feb2021 at 09:30 at a single dose for COVID-19 immunization. Medical history included palpitations controlled by medicine. The patient has no allergies to medications, food, or other products. Concomitant medication included metoprolol (METOPROLOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a little swelling on the site and very little redness when she got the vaccine. However, on the 8th day it was a bigger area, itchy and very red. No pain or other symptoms. The patient did start with a runny nose the day after the vaccine and still have, but not sure it's related. No treatment administered for the events. The events had not resolved. Information on the batch/lot number has been requested.
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| 56 | 2021-02-25 | itchy skin |
Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-o...
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Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 56 | 2021-03-02 | bruising |
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane...
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Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
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| 56 | 2021-03-02 | vaccination site pain |
Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactabl...
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Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.
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| 56 | 2021-03-06 | rash |
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa...
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Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
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| 56 | 2021-03-08 | vaccination site swelling, vaccination site redness, vaccination site pain |
injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swell...
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injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swelling, redness, pain; This is a spontaneous report from a contactable other health professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular, in the right arm, on 05Feb2021 10:00 at SINGLE DOSE for covid-19 immunization. Medical history included allergies (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced injection site swelling, redness, pain on 05Feb2021 10:00. The outcome of event was unknown. Patient did not receive any treatment for the events. No follow-up attempts possible. No further information expected.
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| 56 | 2021-03-14 | itchy rash, rash papular |
Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red...
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Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in the left arm on 30Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included ovarian cancer and chemotherapy; both from 2018 to an unknown date. The patient's concomitant medications were not reported. The patient has not received other vaccine in four weeks. On 01Feb2021 10:00, patient experienced rash to anterior neck, 10x10 cm, raised, red, itching. Outcome of events was recovering. Therapeutic measures were taken as a result of events includes Claritin, steroid and antihistamine. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
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| 56 | 2021-03-14 | hives, itchy skin |
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre...
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annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
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| 57 | 2020-12-31 | hives |
I am a support healthcare worked at a physician's off ice. Therefore, I qualified for the Covid vacc...
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I am a support healthcare worked at a physician's off ice. Therefore, I qualified for the Covid vaccine. At 10:15 am on Thursday 12/31/2020 I received the Pfizer Covid 19 vaccine in my left arm at Hospital. After receiving the vaccine, I went to a 15 minute observation area. At approximately 10:20-10:25, I started to get hives on the left side of my neck below the jaw line. When the nurse circulated by to ask how I was feeling, I reported the start of hives and showed her the location. She asked if I frequently get hives and I said yes. She asked if I had any Benedryl with me. I said I did. She directed me to take 1 - 25 mg tablet and advised would call a physician, who arrived soon after. She observed the hives, asked several questions and then I was taken to ER by wheelchair. I was evaluated by PA, given an IV of steriod, prednisone, and montitored for until 12:20 PM, then was discharged.
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| 57 | 2020-12-31 | injection site swelling, injection site pruritus, injection site redness |
REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY S...
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REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY SWOLLEN, RED AT SITE, AND PT REPORTS VERY ITCHY
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| 57 | 2021-01-01 | injection site pain, injection site bruising |
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired....
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Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
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| 57 | 2021-01-03 | itchy skin |
Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea...
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Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.
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| 57 | 2021-01-04 | injection site pain |
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1...
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48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
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| 57 | 2021-01-04 | tingling |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-04 | itchy skin, rash |
allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and i...
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allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
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| 57 | 2021-01-04 | vaccination site pain |
cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebr...
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cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
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| 57 | 2021-01-04 | vaccination site swelling, vaccination site redness, vaccination site pain |
injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection si...
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injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection site pain, swelling, and redness; This is a spontaneous report from a contactable consumer (patient). A 57 year old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on 28Dec2020 (at the age of 57 years old), at the hospital she works out of, as a single dose in the left arm for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medication was not provided. The consumer reported that she has taken no new medications, and did not receive any other vaccines when she got this one. On the same day, on 28Dec2020, the consumer experienced injection site pain, swelling, and redness. The consumer described the injection site swelling, and redness as a big bullseye, it is a raised knot, and the whole area is red. The consumer reported that she used a tape measure to measure it, and it was only 2 inches by 2.5 inches. The consumer reported that the redness, swelling, and pain she has does not interfere with her day other than she is sore and it is big. Treatment received for the events included icing it off and on. The outcome of the events injection site pain, swelling, and redness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 57 | 2021-01-04 | itchy skin, redness |
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs...
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metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 57 | 2021-01-05 | tingling, itchy skin, rash |
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov...
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Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
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| 57 | 2021-01-05 | tingling, redness |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | itchy skin |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted ge...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted general pruritus without rash, mild scleral injection. No other systemic symptoms. Pt treated with Benadryl 25mg x1. Symptoms resolved within 30-45 minutes.
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| 57 | 2021-01-05 | rash |
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn...
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Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
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| 57 | 2021-01-06 | itchy skin, redness |
57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency...
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57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.
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| 57 | 2021-01-06 | injection site pain |
Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on...
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Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.
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| 57 | 2021-01-06 | redness |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-06 | rash |
at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on ar...
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at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26
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| 57 | 2021-01-06 | tingling |
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt s...
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pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
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| 57 | 2021-01-07 | itchy skin |
Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at...
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Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at scalp. She mentioned this to one of the vaccination nursing staff. This author arrived as discussion was taking place. Itching increasing to torso, began coughing. Denies dyspnea. Placed in wheelchair and taken to ACC without delay. ACC notifed of arrival and was taken directly to Triage. Arrival vitals: 131/85 81 98.5 R- 20 SPO2= 99 RA At ACC - treated with: - Benadryl 25mg IV - Famotidine 20mg IV - Solumedrol 125mg IV - Albuterol Inhaler Improved after meds.
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| 57 | 2021-01-07 | injection site pain | Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative: |
| 57 | 2021-01-07 | injection site pain |
Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol...
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Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.
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| 57 | 2021-01-07 | vaccination site pain |
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection ...
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Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-07 | itchy skin |
Patient complained of generalized itching at 0900. Denied shortness of breath, sweating, hives. 25 ...
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Patient complained of generalized itching at 0900. Denied shortness of breath, sweating, hives. 25 MG of IM Benadryl given at 0936. Patient observed observed after. Patient stated denied itching following Benadryl administration.
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| 57 | 2021-01-07 | tingling, redness |
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ...
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Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
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| 57 | 2021-01-07 | rash, itchy skin | Rash on trunk, Itchiness |
| 57 | 2021-01-07 | vaccination site swelling, vaccination site itchiness, vaccination site redness |
Return of redness, itching, swelling at injection site one week after injection.; Return of redness,...
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Return of redness, itching, swelling at injection site one week after injection.; Return of redness, itching, swelling at injection site one week after injection; Return of redness, itching, swelling at injection site one week after injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 at 07:30 (at the age of 57-years-old) as a single dose for Covid-19 vaccination. Medical history included Multiple Chemical Sensitivity (affecting my respiratory tract) from an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 20:30, the patient experienced a return of redness, itching, swelling at injection site one week after injection. Therapeutic measures were not taken for the redness, itching, swelling at injection site. The clinical outcome of the events redness, itching, swelling at injection site was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 57 | 2021-01-07 | injection site redness, injection site pruritus |
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym...
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Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
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| 57 | 2021-01-07 | tingling |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-08 | rash, hives, itchy skin | Myalgia, SkinRash, Rash & UrticariaPruritus Narrative: |
| 57 | 2021-01-08 | itchy skin |
Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of ...
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Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of obs period.
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| 57 | 2021-01-08 | hives, itchy skin |
Within 15 minutes of vaccine being administered I developed itching then hives on my head which pro...
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Within 15 minutes of vaccine being administered I developed itching then hives on my head which progressed to my upper lip. Took 25 mg benedryl capsule at approximately 25 minutes after vaccine administered. Waited 1 hour at vaccine site to ensure benedryl had been effective at slowing progression of reaction. Hives remained for several hours but no rash or other reaction noted. Also had a large broad hive Penny size at the injection site that still remains 19 hours after vaccine injection.
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| 57 | 2021-01-09 | tingling, itchy skin |
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr...
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Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
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| 57 | 2021-01-10 | itchy skin, hives |
5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List...
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5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List of meds: Pepcid - 20 mg 2 x/day; Satirazine - 10 mg 1 day per day; benydryl 25 mg - several times a day - took over the weekend (over the counter). On 28th they prescribed Prednisone: 20 mg two times/day for five days. There was a fever with the hives so I wasn't allowed to work; off work for six days (three scheduled and three were scheduled off). Resolved after prednisone. Still a bit itchy but no hives.
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| 57 | 2021-01-10 | injection site mass | Dizziness, body ache, lethargic, lump at site of injection for about 5-7 days |
| 57 | 2021-01-10 | hardening, itchy skin |
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C...
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HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
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| 57 | 2021-01-10 | redness, rash | Redness and pain Rash |
| 57 | 2021-01-10 | injection site pain, injection site warmth |
Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling ...
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Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling aching all over. Then the next day, I awoke with a warm area around injection site. Warm to touch, and is very tender.
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| 57 | 2021-01-10 | injection site warmth, redness, injection site redness, injection site pain |
Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no bi...
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Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no big deal. I had some redness, then on the next day, Saturday I started having body aches everywhere, I took two tylenol, and then I was fine. Then when I awoke the next morning, my arm was really sore. The injection site is red and warm and is tender, but not bad bad. The warmth of it is the worst part.
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| 57 | 2021-01-10 | injection site pain | Site Pain, HA, Fever, Joint pain, Body Aches |
| 57 | 2021-01-10 | injection site pain | headache swollen glands in throat injection site soreness |
| 57 | 2021-01-10 | injection site pain |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-10 | injection site swelling, injection site pain, rash |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-11 | tingling |
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ...
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At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
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| 57 | 2021-01-11 | injection site pain |
Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Head...
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Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Headache (three days) Diarrhea (three days) Extreme fatigue (three days)
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| 57 | 2021-01-11 | itchy skin |
itching in hands and feet which progressed to back, neck and head/ later stated her head as well; Th...
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itching in hands and feet which progressed to back, neck and head/ later stated her head as well; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: 5K5730) via an unspecified route of administration in the upper right arm on 19Dec2020 11:00 at a single dose for covid-19 immunisation. Medical history included asthma in 1996, allergies to penicillin, high blood pressure, reflux, allergies, and broke her leg 17 years ago in 2003. The patient has no prior vaccinations within 4 weeks. Concomitant medications included unspecified medications for high blood pressure, reflux, and allergies. The patient previously had allergies with morphine (manifestation: holding hands over ears and felt everyone was screaming at her) and vancomycin. The patient got first dose on 19Dec2020 and is supposed to go back Saturday (09Jan2021) for follow up dose. She wanted to verify if she should get it. After the first injection, it was uneventful the day she got it, and then 4-5 days later, she got itching in hands and feet. It was not so alarming. She still has it and then it started progressing to her back and neck and later stated her head as well. It is not all the time just intermittent. She needed to take Benadryl to keep from scratching so much. Yesterday seemed to be worse. She did not have any hives. Around the end of last week is when it spread to other places besides hands and feet. She doesn't have itching today on back, but she does on her hands and feet. The outcome of the event was not recovered. No ER or physician's office required. She does take daily maintenance medications and she does not know if they are relevant. She also takes medication for high blood pressure, reflux and allergies. She was taking all of them before she took this.
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| 57 | 2021-01-12 | itchy skin, redness |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-12 | tingling |
C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, B...
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C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, BP: 147/82; T: 98.1 DEG. F. 1050: LEFT FACILITY, NO COMPLAINTS.
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| 57 | 2021-01-12 | injection site swelling, injection site redness, injection site pain |
Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, ...
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Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, site redness, swelling and new or worsened joint and muscle pain
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| 57 | 2021-01-12 | injection site swelling, injection site redness, injection site pain |
Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, r...
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Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, redness and swelling and new or worsened joint and muscle pain.
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| 57 | 2021-01-12 | rash |
Systemic: Rash (other than injection site), Systemic: Hyperventilation without airway block from nec...
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Systemic: Rash (other than injection site), Systemic: Hyperventilation without airway block from neck
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| 57 | 2021-01-13 | injection site pain |
Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms start...
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Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms started 10 hours after receiving the vaccination.
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| 57 | 2021-01-13 | vaccination site pain |
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r...
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Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-13 | injection site pain |
Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nau...
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Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
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| 57 | 2021-01-13 | injection site swelling | Swollen injection site, muscle aches, fever (104), fatigue, mild nausea, swollen taste buds |
| 57 | 2021-01-13 | injection site swelling, injection site pruritus |
THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT W...
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THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT WASN'T UNTIL THE PATIENT WAS HOME, ABOUT 11 HOURS POST VACCINATION, THAT THEY REPORTED SWELLING & ITCHINESS AT THE INJECTION SITE, SWOLLEN, TINGLY LIPS AND SWELLING UNDER THE EYES. THE PATIENT REPORTED TAKING BENADRYL, WHICH EFFECTIVELY RESOLVED THE REPORTED SIGNS & SYMPTOMS.
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| 57 | 2021-01-13 | shingles | shingles to lower back after 2nd dose |
| 57 | 2021-01-13 | redness |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-13 | tingling | tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min. |
| 57 | 2021-01-13 | itchy skin, tingling |
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g...
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tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
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| 57 | 2021-01-14 | tingling |
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth...
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20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
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| 57 | 2021-01-14 | injection site pain |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-14 | injection site pain |
Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site sore...
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Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site soreness) Symptoms resolved by the next day with ibuprofen.
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| 57 | 2021-01-14 | rash, itchy skin |
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramp...
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Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
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| 57 | 2021-01-14 | injection site swelling | Local swelling without redness at injection site; rest and told to contact provider if elevates. |
| 57 | 2021-01-14 | rash, itchy skin |
Rash on upper body, extreme itching on face, chin & neck; Rash on upper body, extreme itching on fac...
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Rash on upper body, extreme itching on face, chin & neck; Rash on upper body, extreme itching on face, chin & neck; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 08Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sarcoma Gist (removed on 12Oct2020), seasonal allergies, known allergies: peanut, sesame. The patient's concomitant medications were not reported. On 08Jan2021 20:00, the patient experienced Rash on upper body, extreme itching on face, chin & neck. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-14 | injection site warmth, injection site redness | Red circle appeared on the site where shot was given three days after very warm to touch |
| 57 | 2021-01-15 | injection site rash, injection site redness |
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a...
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Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
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| 57 | 2021-01-15 | injection site discomfort | Pulsing injection site blood pressure was fine at 138/93 |
| 57 | 2021-01-15 | shingles | Shingles |
| 57 | 2021-01-15 | injection site pain | Very painful injection site. Cold, chills, fatigue, overall unwell feeling, exhaustion |
| 57 | 2021-01-16 | itchy rash, rash |
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0...
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I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
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| 57 | 2021-01-19 | injection site pain | Fever, lethargy, pain in arm around injection site, headache |
| 57 | 2021-01-19 | injection site pain |
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w...
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I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
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| 57 | 2021-01-19 | tingling |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-20 | vaccination site pain |
tenderness at injection site; This is a spontaneous report from a contactable other hcp (patient). T...
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tenderness at injection site; This is a spontaneous report from a contactable other hcp (patient). The 57-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, lot number: EK4176), on left arm unknown on 09Jan2021 13:30 at SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient did nor receive other vaccine in four weeks. The patient did not experience COVID prior the vaccination. The patient did not test covid post vaccination. No known allergies. Concomitant medication included alprazolam (XANAX), cetirizine hydrochloride (ZYRTEC DAIICHI), omeprazole (PRILOSEC), zolpidem tartrate (AMBIEN). The patient experienced tenderness at injection site on 10Jan2021 05:00, described as Woke up the next morning with tenderness at injection site. No swelling or redness. No treatment received for the event. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.
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| 57 | 2021-01-21 | rash, injection site warmth, injection site pruritus, injection site mass, injection site hardening, injection site redness |
2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the in...
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2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the injection site. Symptoms progressed to a patch of redness,diffuse and bumpy induration, and warmth measuring approximately 8x10 cm. Skin is intact with no pustules or vesicles. Indistinct margins. No symptoms or involvement of the inner aspect of the arm or axilla. No adenopathy. Have used topical Hydrocortisone and oral Benadryl with some relief, but symptoms persist now 6 days post vaccine. Symptoms are enough to wake me at night due to arm itchiness and discomfort.
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| 57 | 2021-01-21 | injection site pain | Headache, dizziness and severe pain at injection site |
| 57 | 2021-01-21 | rash |
Pfizer-BioNTech COVID-19 Vaccine EUA Rash patch on both sides of neck, rash on both sides of upper c...
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Pfizer-BioNTech COVID-19 Vaccine EUA Rash patch on both sides of neck, rash on both sides of upper chest (size of an orange), rash on inside of upper arms. Started 1/9/2021 Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on left side of lower back. Started 1/15/2021. Treatment tried without relief - Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
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| 57 | 2021-01-21 | rash |
Pfizer-BioNTech Covid-19 vaccine EUA Rash patch on both sides of neck, both sides of upper chest (si...
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Pfizer-BioNTech Covid-19 vaccine EUA Rash patch on both sides of neck, both sides of upper chest (size of orange), inside of upper arms. Started 1/9/2021. Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on lower left side of back. Started 1/15/2021. Treatments tried-no relief - Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
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| 57 | 2021-01-21 | injection site swelling, injection site pain | chills, headache, body aches, pain and swelling at the injection site |
| 57 | 2021-01-24 | tingling | Immediately felt numbness and tingling in arm and fingers |
| 57 | 2021-01-25 | redness, rash macular |
Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red...
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Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red and blotchy. She states she feels the need to frequently clear throat but is not short of breath. She states her lips feel tingly. No angioedema noted, redness is not spreading from palms of hands. No redness or rashes noted at injection site. Pt was given 50mg of diphenhydramine prior to leaving. She waited in lobby with staff observation for another 15 minutes, Redness in hands was resolved. Educated pt to call emergency services should symptoms persist or worsen. Pt verbalizes understanding. This RN will call later today and tomorrow to follow up with pt.
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| 57 | 2021-01-25 | redness |
Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no ...
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Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no pain. Tues. 1/26 had 30 seconds where it was hard to breathe, "like gasping for air".
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| 57 | 2021-01-25 | vaccination site pain |
Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This...
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Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
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| 57 | 2021-01-26 | itchy skin, rash |
Itching and rash over whole body starting the day after injection and continuing now for 5 days from...
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Itching and rash over whole body starting the day after injection and continuing now for 5 days from head to toe.
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| 57 | 2021-01-26 | injection site pain |
Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post inje...
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Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post injection, pain and tenderness around injection area.
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| 57 | 2021-01-26 | skin infection at injection site | cellulitis at injection site, treated with oral antibiotics, gradually improving |
| 57 | 2021-01-27 | vaccination site pain, vaccination site swelling |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-28 | tingling |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-31 | injection site pain |
Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am C...
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Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.
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| 57 | 2021-02-03 | tingling |
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over an...
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Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
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| 57 | 2021-02-07 | rash |
hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist....
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hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-08 | tingling | Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911. |
| 57 | 2021-02-10 | itchy skin |
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca...
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bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | tingling |
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness...
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numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | injection site pain |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-17 | tingling |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-21 | shingles | Developed Shingles, approx 7 days after 2nd dose after 2nd dose |
| 57 | 2021-02-21 | injection site pain |
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,...
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Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
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| 57 | 2021-02-21 | hives |
Hives primarily on left side of face/cheek. Just observed, about 4 hours after it diminished 75%, ...
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Hives primarily on left side of face/cheek. Just observed, about 4 hours after it diminished 75%, I took one Benadryl at bedtime just in case, next morning it was gone.
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| 57 | 2021-02-21 | itchy skin |
Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2...
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Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2/22/21 at 14:38 pm/ Pt. states that she started having itching shortly afterwards. Pt. denies shortness of breath, denies
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| 57 | 2021-02-21 | skin burning sensation | Rapid heart rate Burning through body Cold sweat Felt low blood pressure |
| 57 | 2021-02-22 | rash |
developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she als...
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developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she also had fever, chills aches 10 hours after the vaccine and that lasted 24 hours.
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| 57 | 2021-02-23 | injection site pain |
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ...
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Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
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| 57 | 2021-02-23 | skin burning sensation |
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;...
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I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-02-23 | itchy skin, injection site pain |
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me...
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Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
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| 57 | 2021-03-02 | hives |
seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medi...
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seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event "She has hives wrapped around her entire left ankle". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination. Information on the lot/batch number has been requested (clarification).
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| 57 | 2021-03-03 | hives |
Hives on both arms about 5 hours after second injection. Spread to my legs 5 days later; This is a s...
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Hives on both arms about 5 hours after second injection. Spread to my legs 5 days later; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 27Jan2021 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included metformin, colecalciferol (VITAMIN D), biotin and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) on 06Jan2021 13:45 in the left arm at the age of 57 years old for Covid-19 Immunization. On 27Jan2021 18:00, the patient experienced hives on both arms about 5 hours after second injection which spread to the patient's legs 5 days later. The patient saw her PCP today and she felt it was related to vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included antihistamine. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
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| 57 | 2021-03-08 | itchy skin, rash, hives |
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain...
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Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
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| 57 | 2021-03-14 | redness, hives, itchy skin |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-14 | shingles, rash |
Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen ...
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Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen by her PCP and was reportedly being treated for Shingles. Missed work week of 8-12 March for same. When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home.
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| 58 | 2020-12-31 | rash |
Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which t...
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Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.
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| 58 | 2020-12-31 | itchy skin, rash macular, redness |
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ...
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Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
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| 58 | 2021-01-02 | rash, redness, itchy skin, hives |
Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylpre...
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Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylprednisolone, and applied hydrocortisone. Had to reside after 4-5 hrs, and again the next morning. Went to urgent care clinic and received 60 mg depo-prednisolone and went home and took more Benadryl and applied more hydrocortisone cream. Rash all over the body.
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| 58 | 2021-01-03 | hives, rash |
12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day. 12/3...
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12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day. 12/31/2020 developed hives on abdomen, back and thighs. She started diphenhydramine 1/2/2020 and rash still seemed to be worse
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| 58 | 2021-01-03 | rash |
A rash appeared on my lower left arm and has spread a bit to my upper arm. Each day the rash is mor...
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A rash appeared on my lower left arm and has spread a bit to my upper arm. Each day the rash is more widespread although there is no fever, no itching, no raised bumps. I contacted my doctor who provides care management for lymphedema, and provided pictures of the rash. He agrees it is not a cellulitis infection but can provide no further information and did not ask me to come for an appointment.
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| 58 | 2021-01-03 | itchy rash, rash | Face rash, itchy for 2 days, (face and neck) Face warm to touch, Seen by NP no treatment |
| 58 | 2021-01-03 | skin burning sensation, redness, itchy skin |
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my ...
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S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
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| 58 | 2021-01-03 | injection site pain |
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject...
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The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
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| 58 | 2021-01-04 | itchy skin |
Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contacta...
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Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office. The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine. There were no adverse events (AEs) following prior vaccinations. There were no relevant tests performed.
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| 58 | 2021-01-05 | rash |
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s...
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Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-05 | tingling |
LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYS...
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LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN
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| 58 | 2021-01-05 | injection site pain | Metallic taste; injection site pain Narrative: |
| 58 | 2021-01-05 | shingles | SHINGLES |
| 58 | 2021-01-05 | vaccination site itchiness, vaccination site pain, vaccination site swelling |
injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the inje...
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injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the injection site; itchiness at injection site; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper left arm) on 21Dec2020 (between 9:00AM and 9:30AM) at single dose for Covid-19 immunization. Medical history included allergic to dust mites and grass, summertime allergies (haven't been diagnosed but she has sneezing and watery eyes during the summer), obese at 190, and flu vaccine in Oct2020, and smoker. Her mother passed from COPD and stated that more than likely she has that because she is a smoker. Her father had congestive heart failure. Concomitant medications were not reported. The patient previously took flu vaccine vii and experienced migraine; also, previously took Novocaine (probably 10 to 15 years ago) out of the blue she had a reaction. "Eons ago" when she was probably 25 she had a reaction to the very first flu shot that she got. The reaction was a migraine and she could not get out of bed. The patient wanted to know if it was normal to have side effects a week later after receiving Covid vaccine. She received vaccine on 21Dec2020 and today (29Dec2020 5AM) she was experiencing injection site tenderness, appearing swollen at injection site, and itchiness at injection site. It was further reported that she woke up this morning and her arm is itchy. It is swollen at the injection site. It is about the size of a fifty-cent piece. It is itchy and it is a little tender. The patient added, "It is a little tender": it was a little sore the first day like a flu shot. It is annoying like a bug bite itch. The swelling has been the same throughout the day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered. Information on the Lot/batch number has been requested.
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| 58 | 2021-01-06 | injection site pain |
"By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the i...
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"By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the injection site was a little tender but i could move the arm"
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| 58 | 2021-01-06 | rash, hives |
2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2d...
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2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-01-06 | skin burning sensation |
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset wors...
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Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
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| 58 | 2021-01-06 | rash, hives |
hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and i...
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hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning); This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 29Dec2020 10:30 at single dose for COVID-19 Immunization. No medical history. No family medical history. There were no concomitant medications. Patient received first dose last Tuesday, 29Dec2020, at the hospital. The next day, she had a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning). It was a pretty severe case of hives on her legs now (31Dec2020). Spread to legs and now has hives on legs was reported as worsened. Physician's office visit involved. She had a question. Her doctor prescribed a dosing pack of prednisone to get rid of the hives and her question was, will it affect the effectiveness of the vaccine if she takes it, also, is it ok to get 2nd dose in 2 weeks. She confirmed she had not taken the prednisone yet. There was no prescriber. She received it because she is a healthcare worker. Patient asked if there is any recommendation on getting pre medicated with ex: Benadryl before getting the vaccine. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect product. No medications prior vaccinations (within 4 weeks). No test done. This is a serious report. The slight rash on abdomen, spread to legs and now has hives on legs was considered medically significant per reporter. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-06 | hives | hives, burning sensation around mouth |
| 58 | 2021-01-07 | redness |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-07 | skin spots |
Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginn...
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Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginning on her legs and spreading to abdomen and arms.
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| 58 | 2021-01-07 | rash macular, tingling |
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton...
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Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
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| 58 | 2021-01-07 | itchy skin | Itching of skin generalized and controlled with Benadryl |
| 58 | 2021-01-07 | hives, rash, itchy skin | Rash & UrticariaPruritus |
| 58 | 2021-01-07 | rash |
Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from...
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Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on 28Dec2020 at 15:00 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included arthritis, hypothyroidism and chronic back pain and arthritis in back; all from unspecified dates and unspecified if ongoing. It was reported that the patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications (taken in two weeks) included duloxetine hydrochloride, levothyroxine, nortriptyline and methocarbamol (ROBAXIN); all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020 at 19:00 the patient experienced a "rash on my face across my nose and cheeks" and on 30Dec2020 the patient experienced "rash on neck and chest". It was reported that "the evening after my vaccine I developed a rash on my face across my nose and cheeks. The next day I developed a rash on my neck and chest and the rash on my face was gone. I still have a rash on my neck and chest. No fever or other symptoms." It was reported that the adverse events were non-serious and did not require treatment nor hospitalization. The clinical outcome of the event "rash on my face across my nose and cheeks" was recovered/resolved on an unspecified date and the outcome of the event "rash on neck and chest" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-07 | hives, itchy skin |
Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contac...
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Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 02Jan2021 at single dose as reported for "Indication: Consumer stated, "Because I work in Covid testing, in healthcare." Medical history included hypertension and allergy. Concomitant medication included amlodipine, lisinopril, metoprolol, hydrochlorothiazide (HYDROCHLORZIDE), desloratadine and montelukast. The patient stated, "had the first dose of the Pfizer vaccine yesterday for the Covid 19, 2 hours after I started itching and it has been different places all over my body. I do not know has it anything to do with the way that it goes through the body, I do not know. I have had to take a lots of Benadryl. I have had to take some steroids that I had here at the house I never had started and I thought it was okay. Last night my husband put hydrocortisone cream (later clarified as treatment) on areas I was itching and had hives. I slept all night I did not have any problem since I got up this morning I started itching in other place. So, I have done the whole thing again. I am going to has to go. I did not want to go ER because I am not having trouble on breathing or anything like that but I have got various places it is like different places every time it starts. So, I need to I am going to go and have a probably a strong steroid shot and have strong steroid given to me, not for oral but I just want to let you know if that is a side effect and I do not know whether I am going to take the second one or not?" I have taken Benadryl and I have taken Methylprednisolone and I have used on the Cortisone Cream, the topical cream". The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the events rash, pruritus and urticaria cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-07 | rash | Severe Headache Rash starting on neck and chest Chills Fever Vomiting |
| 58 | 2021-01-07 | injection site pain, injection site swelling, injection site redness | Vaccine injected too low on injection site, causing pain, redness and swelling. |
| 58 | 2021-01-07 | injection site redness, injection site warmth, injection site swelling | Vaccine injected too low, causing redness, warmth, swelling and pain at injection site. |
| 58 | 2021-01-07 | vaccination site pain |
severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her ...
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severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
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| 58 | 2021-01-08 | tingling |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | tingling | Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours. |
| 58 | 2021-01-08 | tingling |
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya...
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Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
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| 58 | 2021-01-09 | pain of skin |
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba...
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10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
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| 58 | 2021-01-09 | hives | Hives on both arms upper torso Benadryl every 4 hours is planned |
| 58 | 2021-01-10 | hives |
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to...
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Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
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| 58 | 2021-01-10 | tingling |
Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symp...
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Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symptoms started on 01/04/2021 is still present, however, patient admits to symptoms improving. Patient received medical care from primary care provider however they could not determine any causes and was advised to keep monitoring the symptoms.
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| 58 | 2021-01-10 | rash | Rash arms, thighs, lower back |
| 58 | 2021-01-10 | injection site pain |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-10 | injection site swelling, injection site redness |
significant redness and swelling at site of injection, gradually spread up to top of shoulder, over ...
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significant redness and swelling at site of injection, gradually spread up to top of shoulder, over 4 days Patient had previously had COVID 19 disease, and recovered, in August 2020
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| 58 | 2021-01-10 | vaccination site pain |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | injection site pruritus, injection site pain |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-11 | injection site swelling, itchy skin, injection site redness, injection site pain, hives |
lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swe...
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lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events "redness, swelling and tenderness at injection site" and "slightly itchy scalp" resolved on 25Dec2020, the event "Cold blister on lip" resolved on 03Jan2021. The event "Swelling on the right side of the base of her neck near her clavicles" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-11 | injection site pain | sore arm where injection was given shortly after. |
| 58 | 2021-01-11 | injection site swelling, injection site pruritus, rash papular, skin discolouration, injection site redness, injection site pain |
swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after ...
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swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after 7 days post injection that increased in area. Burning sensation experienced. Skin still discolored more than 20 days after 1st shot. 2nd dose in right arm: same reaction within 48hrs. redness, burning , itchiness sensation spreading to upper arm.
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| 58 | 2021-01-12 | injection site pain |
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTE...
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ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTED 48-72 HOURS BEFORE RESOLVING.
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| 58 | 2021-01-12 | injection site pain |
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-7...
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ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-72 HOURS.
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| 58 | 2021-01-12 | tingling | Patient reports tingling and burning sensation at the tips of her right fingers. |
| 58 | 2021-01-12 | vaccination site warmth, vaccination site redness, vaccination site swelling |
Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised ...
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Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised at injection site.; Chills; Low grade fever; Fatigue; Body ache; This is a Spontaneous report from a contactable nurse (reported for herself). A 58-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), intramuscular on 04Jan2021 12:30 at single dose at right arm for COVID-19 immunization. Medical history included Vasculitis, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included azathioprine (IMURAN [AZATHIOPRINE]), chlorthalidone, duloxetine hydrochloride (CYMBALTA), hydroxychloroquine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 14:00, the patient experienced red, hot and raised at injection site. 18 hours after receiving, she developed chills, low grade fever, fatigue and body ache on 05Jan2021. Treatment received for the adverse events included Tylenol. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
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| 58 | 2021-01-12 | rash |
was told by occupational health that rash reporting was mandatory. Rash noted over entire trunk and...
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was told by occupational health that rash reporting was mandatory. Rash noted over entire trunk and all extremities, sparing head, hands, and feet
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| 58 | 2021-01-13 | injection site pain |
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When...
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"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
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| 58 | 2021-01-13 | rash |
Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid b...
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Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid benedryl for the minor allergic reaction.
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| 58 | 2021-01-13 | injection site pain |
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ...
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Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
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| 58 | 2021-01-13 | hives |
sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had...
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sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had to go to emergency room and get some Benadryl and stay and be monitored for hour.
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| 58 | 2021-01-13 | redness | swelling, redness, warmth |
| 58 | 2021-01-14 | itchy skin, skin burning sensation |
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz...
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After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
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| 58 | 2021-01-14 | tingling |
Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little...
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Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
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| 58 | 2021-01-14 | tingling |
Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airw...
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Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airway compromise, SOB, CP, or dizziness. Transported to ED from vaccine clinic.
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| 58 | 2021-01-14 | skin burning sensation |
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach...
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Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
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| 58 | 2021-01-16 | injection site swelling, itchy skin, redness |
Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hr...
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Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hrs later, stiffness in right upper trapezius and shoulder, took 440 mg naproxen and felt great! 24 hours after 2nd dose, redness. Itching and swelling at injection site. Tired, cold, temp 100.4. Applied ice 20 min on/off throughout day, took ibuprofen 1/16/21. Today 1/17/21, still red, warm to touch and itchy. I took a photo because I couldn?t tell if red area bigger. temp 99.4, slight headache
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| 58 | 2021-01-17 | rash, itchy skin |
awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs...
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awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs; huge rash on her legs front and back but not on torso only on neck; This is a spontaneous report from a contactable nurse (patient) reported that a 58-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included omeprazole magnesium (PRILOSEC). The patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, EL1284) on 18Dec2020 at 6:00 AM on the right arm. The patient reported that on a cupid days (as reported) after vaccine, she broke out in huge whips and rash from her face to the bottom of torso, it did this twice, so severe had she had to be put on a dose pack. The patient then received her second dose 08Jan2021 and awakes around 3 am with severe itching on my legs and this time huge rash on my legs front and back but not on torso only on neck on 08Jan2021 (as reported). The patient took Benadryl. The outcome of the events pruritus and rash was recovered while the outcome of the event was unknown. The patient had not been tested for COVID-19 post vaccination. Information on the lot/ batch number has been requested.
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| 58 | 2021-01-19 | redness |
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21...
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1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
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| 58 | 2021-01-19 | hives |
1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 mo...
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1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 moved via w/c to private observation with EMT on site in Gave patient ice packs for both arms. States that the ice reliefs to burning. attendance. HR 78; O2 97%. Unable to obtain BP due to obesity. Per exam noted on Left lower arm a solid red raised area about 3 inches in diameter about 1/8 cm height. States it burns. Has mildly red scattered hive like areas on right lower arm. 2:15 Gave patient ice packs for both arms. States that the ice reliefs to burning.. Denies any burning or swelling in throat. BBS CTA per EMT assessment. No shortness of breath note; 2:25 States she drove on her own and lives in a senior adult complex. EMT recommended ambulance for further evaluation. Patient declined. EMT instructed patient to contact medical physician or emergency if problems persist or if symptoms worsen. Patient agreed and left ambulatory to private vehicle.
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| 58 | 2021-01-19 | redness, itchy skin |
Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest an...
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Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest and back of her neck which was mildly itchy and burning. She took Benedryl 25 mg prior to the vaccine and 25 mg after the symptoms appeared. Symptoms resolved within about 24 hours.
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| 58 | 2021-01-19 | injection site pain | Chills, seizure like activity, body aches, injection site soreness |
| 58 | 2021-01-19 | itchy skin |
I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pin...
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I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pinna. The tip of my tongue also became numb. Symptoms lasted for 45 minutes.
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| 58 | 2021-01-19 | tingling |
Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes ...
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Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes after receiving vaccine and lasted 45-60 minutes.
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| 58 | 2021-01-19 | rash | Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Severe, Systemic: Vertigo-Severe |
| 58 | 2021-01-21 | rash, itchy rash, blister, pain of skin |
Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thur...
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Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thursday rash had spread to legs, back, and neck. Pruritic rash that is tender to touch. Diarrhea began Thursday, 4-5 episodes in 1 day. Fatigue also began Thursday. Has tried 25mg benadryl on Wednesday and Thursday with no relief. No fever.
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| 58 | 2021-01-21 | vaccination site redness, vaccination site pain, vaccination site itchiness, vaccination site warmth, redness, itchy skin |
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o...
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This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
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| 58 | 2021-01-21 | itchy skin | itching all over my face; elevated blood pressure; increased breathing rate |
| 58 | 2021-01-24 | itchy skin |
9:20 Feeling Itchy Heart rate 80 Blood pressure 112/68 9:30 symptoms better, apple juice given 9:3...
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9:20 Feeling Itchy Heart rate 80 Blood pressure 112/68 9:30 symptoms better, apple juice given 9:37 heart rate 80 blood pressure 108|68 symptoms have stopped 9:40 No rash, hives or difficulty breathing. Works at hospital to inform supervisor for any further problems
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| 58 | 2021-01-24 | rash |
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev...
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Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
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| 58 | 2021-01-24 | injection site pain |
Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or ki...
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Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or kidney stones)
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| 58 | 2021-01-25 | itchy skin |
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI...
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PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
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| 58 | 2021-01-25 | vaccination site pain |
Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a conta...
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Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unspecified lot number, reported as EH9899 or TH9899), intramuscularly at site of right arm at 10:00 on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN, lot number: 300045; Expiration date: May2022) from Jan2021. The patient previously took cetirizine hydrochloride (ZYRTEC) daily for allergies forever. Clinical course: Patient received the first dose of the BNT162B2 on 20Dec2020, and was tired afterwards, she didn't feel tired continually. She began to feel tired on 21Dec2020, she was just exhausted, she was so tired and she just slept, she couldn't get out of her own way. On 22Dec2020, she was fine, but on 23Dec2020, she began to feel tired and exhausted again. By 24Dec2020, her symptoms were over. She also experienced injection site pain in her right arm that started on 21Dec2020 and resolved by the evening of the same day. No treatment received for this event. Vaccination Facility Type was in hospital. No vaccine administered at Military Facility. No emergency room visit needed. It was unknown that physician office visit needed. No prior vaccinations within 4 weeks. Adverse event(s) following prior vaccinations was N/A. Family medical history relevant to adverse event(s) was not provided. Relevant tests were none. The outcome of event 'tiredness/exhausted' was recovered on 24Jan2021; of event 'injection site pain in her right arm' was recovered on 21Dec2020. Information on the Lot/Batch number has been requested.
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| 58 | 2021-01-25 | hives |
hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hiv...
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hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hives are worse; first dose on 21Dec2021, second dose on 08Jan2021; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (Lot: EL3246), via an unspecified route of administration in right arm on 08Jan2021 08:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included meloxicam. The patient previously received the first dose of BNT162b2 (Lot: EK5730), at the age of 58-year-old, via an unspecified route of administration in right arm on 21Dec2020 at single dose for covid-19 immunization. She is not allergic to anything at all. She got the 2nd shot on Friday (08Jan2021) 8:45 and then on Sunday (10Jan2021) she had hives from head to toe. She has not tried anything new, no food, products, or detergents. She has no hives at the injection site. Her Hives are on her ears, lips, neck, going all the way down to her toes. At 4 o'clock on 10Jan2021 if when the hives began and by 6 the hives had exploded. Her Hives are worse now. She has had No Positive tests for Covid prior to the vaccine. She has had no antibody test prior to the vaccine. She has had No issues with vaccines in the past. She is using Benadryl to treat her Hives, however it puts her to sleep in 30 minutes and so she cant do that at work. The patient received the first dose on 21Dec2021, second dose on 08Jan2021. The outcome of the event hives was not recovered.
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| 58 | 2021-01-26 | vaccination site pain |
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ...
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Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
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| 58 | 2021-01-26 | injection site pain |
extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through ...
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extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal. (98.4) Body aches, and nausea most of the day on 1/21/2021. treatment: Ibuprofen 600mg BID X 2 days.
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| 58 | 2021-01-26 | redness |
maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet...
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maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL246 and expiry date: unknown), via an unspecified route of administration, left arm on 11Jan2021 09:45 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 10:30 (lot number: EJ1685) on the left arm. Medical history included mild asthma GERD (gastrooesophageal reflux disease, and allergies to certain antibiotics causing a rash. Patient was not pregnant. Concomitant medication included montelukast sodium, omeprazole, and colecalciferol (VITAMIN D). The adverse events began as maculopapular rash on abdomen now redness covering trunk and extremities, sparing head, hands, and feet on 12Jan2021. Outcome of the events was not recovered. No treatment for the events was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 58 | 2021-01-28 | injection site pain |
2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (l...
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2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (level 9). I began taking Tylenol which caused the pain to subside to a reasonable level. I took Tylenol every 6 hours to keep the pain in my arm, which seemed to cause some neck stiffness, down to a 2 or 3 level (10 being the worst pain). The next morning pain was down to 1 or 2 level, I took Tylenol again. By noon the second day pain was gone.
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| 58 | 2021-01-28 | injection site pain | Fever blister on upper lip (herpes simplex1) Slight tenderness at injection site |
| 58 | 2021-01-28 | tingling |
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat...
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Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
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| 58 | 2021-01-28 | hives |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-28 | vaccination site pain | sore body and muscles, vaccine site extremely sore headache and fatigue. |
| 58 | 2021-01-31 | rash |
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E...
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chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
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| 58 | 2021-02-02 | injection site pain |
feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only wo...
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feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day. All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021. Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-11 | hives | facial/ tongue swelling, hives, shortness of breath, trouble swallowing |
| 58 | 2021-02-13 | injection site pain, tingling |
My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI...
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My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
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| 58 | 2021-02-15 | blister, rash |
Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing ...
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Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall.
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| 58 | 2021-02-21 | itchy rash, hives, injection site pain |
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ...
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The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
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| 58 | 2021-02-21 | injection site pain | soreness at injection site. then a mild migraine the following evening. |
| 58 | 2021-02-22 | injection site pain |
Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discolorati...
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Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)
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| 58 | 2021-02-22 | shingles, rash |
shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is ...
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shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now. The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-23 | tingling, vaccination site swelling, vaccination site pain |
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that...
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had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
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| 58 | 2021-02-25 | rash macular, skin spots |
I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a con...
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I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient (not pregnant at the time of vaccination) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration on 02Feb2021 13:30 in left arm at single dose for covid-19 immunisation. Medical history included known allergies: Amoxicillin (all penicillin family), she had AT III deficiency (a hereditary blood clotting disorder) that she had been taking warfarin for 23 years never any issues or clots since. she had never had a reaction to any vaccines before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included warfarin for AT III deficiency and 1 multi vitamin. The patient previously took amoxicillin and experienced allergies. On 02Feb2021 the patient got the vaccine at 1:30pm. At 5:30 pm, she saw bright red dots and dot clusters on both legs (not sure when it started, reported as 02Feb2021 05:00 PM) all dots were under the surface of her skin. They didn't itch nor hurt and were not detectable by touch. She took a few pictures. Next day they were still there and hadn't increased or decreased. The next day Thursday, she went to her PCP Dr (Name) got blood work and results came back normal. He thought it to be petechiae but not sure why. Each day the red dot/clusters turned more purple and within 5-7 days had faded away. Dr. (Name). said if with the second vaccine dose, she got worse dot/clusters that worry her, she was to come back. On 12Feb2021 she had an appt with her hematologist Dr (Name), after discussing and looking at the pictures (knowing that she had never had this before) she said it was not related to her medical condition-AT3 deficiency, it didn't look like petechiae. She said it was a reaction to the vaccine, to report it and get advice from you folks before got the second dose. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Feb2021. The events were reported as non-serious by the reporter.
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| 58 | 2021-02-28 | tingling |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT1...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.
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| 58 | 2021-03-02 | rash, itchy skin |
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ...
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High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
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| 58 | 2021-03-02 | vaccination site redness, vaccination site swelling |
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s...
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slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 58 | 2021-03-14 | tingling, shingles |
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her h...
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She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 59 | 2020-12-31 | tingling |
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE...
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DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
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| 59 | 2021-01-01 | injection site pain |
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h...
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I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
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| 59 | 2021-01-02 | hardening |
Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe ...
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Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.
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| 59 | 2021-01-03 | tingling |
Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling...
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Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out. It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face. It lasted with the same intensity for 3 days. It then started to subside slowly for the next 3 days and then was totally gone.
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| 59 | 2021-01-04 | injection site pruritus, injection site redness, tingling, itchy skin, hives |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | injection site pain |
Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose ...
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Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.
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| 59 | 2021-01-04 | vaccination site itchiness |
Itching at injection site; This is a spontaneous report from a contactable Other health care profess...
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Itching at injection site; This is a spontaneous report from a contactable Other health care professional (HCP) reporting for herself. A 59-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 23Dec2020 at 06:30 PM at single dose for COVID-19 immunization. Medical history included breast cancer (Currently healthy). Concomitant medications included Tamoxifen and vitamin D. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 25Dec2020 patient experienced Itching at injection site. No treatment was received for the event. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had not recovered from the event at the time of the report. Information about lot/batch number has been requested.
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| 59 | 2021-01-04 | tingling |
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED...
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Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
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| 59 | 2021-01-04 | injection site redness, injection site swelling, injection site pain |
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t...
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Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol. Â Disposition: Patient declined ED visit
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| 59 | 2021-01-04 | itchy skin |
STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON ST...
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STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON STEROIDS TODAY.
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| 59 | 2021-01-04 | shingles |
developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. ...
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developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered. Information on the lot/batch number has been requested
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| 59 | 2021-01-04 | vaccination site pain |
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ...
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pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
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| 59 | 2021-01-05 | injection site pain |
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ...
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1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
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| 59 | 2021-01-05 | tingling |
Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes afte...
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Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection
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| 59 | 2021-01-05 | itchy skin, injection site pain, rash |
On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very...
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On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on
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| 59 | 2021-01-05 | tingling |
This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had g...
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This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
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| 59 | 2021-01-05 | hives, itchy skin | UrticariaPruritus |
| 59 | 2021-01-05 | rash | generalized rash. resolved in 2 days with benadryl. |
| 59 | 2021-01-06 | redness, swelling |
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the...
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Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
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| 59 | 2021-01-06 | itchy skin |
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho...
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Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
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| 59 | 2021-01-06 | tingling |
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/...
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Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
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| 59 | 2021-01-06 | rash papular, rash | raised rash on right arm |
| 59 | 2021-01-06 | hives |
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore...
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stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
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| 59 | 2021-01-07 | tingling |
Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizzi...
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Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs. Patient was monitored for an additional 20 minutes and symptoms resolved. Patient had no other complaints.
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| 59 | 2021-01-07 | tingling |
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes...
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From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
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| 59 | 2021-01-07 | redness, itchy skin |
HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO...
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HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO ER
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| 59 | 2021-01-07 | injection site pain | Mild headache and injection site soreness |
| 59 | 2021-01-07 | injection site pain | Mild headache and injection site tenderness |
| 59 | 2021-01-07 | itchy rash | Rash with itching. 01/04/2021 prednisone 60mg, 40mg, 20mg-3 day taper. |
| 59 | 2021-01-07 | itchy skin |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-07 | hives |
sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well...
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sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well, hives
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| 59 | 2021-01-07 | tingling | tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called |
| 59 | 2021-01-08 | skin discolouration |
Developed fever/chills next day and following day which resolved but also began having having purple...
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Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.
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| 59 | 2021-01-08 | injection site pain | soreness and stiff yat the die if injection for 2 days took tylenol to treat pain |
| 59 | 2021-01-09 | rash papular, redness, injection site pain, tingling, rash |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-09 | injection site pain |
Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by...
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Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by 4:30 pm the day after the shot For a few hours about 8 hours after shot, arm where shot was given was quite sore, but that went away
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| 59 | 2021-01-09 | injection site pain | Reaction site pain, fatigue, chills and joint pain |
| 59 | 2021-01-09 | injection site pain |
Six hours after being administered by the vaccine I started to feel soreness around the site. Within...
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Six hours after being administered by the vaccine I started to feel soreness around the site. Within the hour it progressed to pain in my left upper arm radiating down to my lower arm. By this time, I had difficulty raising my arm and limited ROM. This continued for three days. The symptoms eased up a little bit but there was constant pain whenever I raised my affected arm. When I went to work on the night of the Jan third, I felt my arm hurting during the night. I took ADVIL for the pain and continued to do so. Jan 6 and 7 At night, I was awoken with excruciating pain on the same arm. This lasted for approximately a couple of mins. I sought a virtual consultation with my PCP who advised me to take ten days off from work. I am currently on medical leave. I haven't experienced the same excruciating pain as I had those two nights. However, my ROM is still limited because there is still moderate pain involved. I've stopped taking Advil since it has started to upset my stomach.
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| 59 | 2021-01-09 | injection site pain | Temperature 99.4, severe body aches, chills, soreness at injection site |
| 59 | 2021-01-10 | itchy skin, injection site pruritus |
25 min after injection and said she had itching all over her body started at the injection site then...
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25 min after injection and said she had itching all over her body started at the injection site then spread throughout her body. She was sent to an NP for evaluation. They advised her to take a BENADRYL and see if that resolved. She came back at 1700 to let us know she was somewhat better but would go home and take an additional BENADRYL. Recommended she contact her primary if symptoms persist or go to UC.
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| 59 | 2021-01-10 | injection site redness, itchy skin, injection site swelling |
Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen ar...
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Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen area where shot was given
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| 59 | 2021-01-10 | injection site pain | In afternoon had chills headache fatigue injection sit deltoid sore down to elbow |
| 59 | 2021-01-10 | rash | Rash entire body, throat swelling, extreme nausea. |
| 59 | 2021-01-10 | itchy skin |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-10 | rash, itchy skin |
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw...
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That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
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| 59 | 2021-01-10 | itchy rash |
red rough rash, itchy onset 01/06/21 seen PCP treated with Kenalog injection and MEDROL DOSE PACK 6...
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red rough rash, itchy onset 01/06/21 seen PCP treated with Kenalog injection and MEDROL DOSE PACK 6 DAY
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| 59 | 2021-01-10 | injection site pain | sore arm at injection site. Swollen and painful L shoulder on site of injection |
| 59 | 2021-01-10 | tingling |
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o...
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sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
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| 59 | 2021-01-10 | injection site pain |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-11 | hives, rash |
2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen betwe...
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2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen between 8-10pm on Saturday, 1/9/2021 which included hives around neck and covering chest torso and arms. Treated with topical Benadryl. Rash/hives continued to persist spread to entire body, head, neck, face, torso, arms, legs, feet. On early Monday, 1/11/2021 - Contact with Employee Health Nurse and PCP Dr. and advised to take Benadryl as the only symptom was the rash/hives - no facial swelling or shortness of breath. Tuesday, 1/12/2021 after taking advice of Employee Health Nurse and PCP symptoms are nearly fully resolved.
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| 59 | 2021-01-11 | rash macular, tingling |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | hives | Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl |
| 59 | 2021-01-11 | tingling |
Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and ...
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Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and then goes away. Some tingling in upper extremities noted initially , but none now. Patient declined to remain longer for observation. She had her husband here for transportation home. Advised patient to call Health Services if other symptoms occurs She will do this. Advised ER if symptoms emergent.
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| 59 | 2021-01-11 | injection site warmth, injection site mass, injection site redness | noted hard lump at injection site, warm, redden, sore Headache, very tired |
| 59 | 2021-01-11 | tingling |
numbness in right fingers along with tingling. moved to back of neck and side of face. right side ...
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numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-11 | rash |
rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This...
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rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious. Information on the lot/batch number has been requested
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| 59 | 2021-01-12 | rash, itchy skin |
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under...
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Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
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| 59 | 2021-01-12 | injection site pain | Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved. |
| 59 | 2021-01-12 | hives, itchy skin |
Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:3...
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Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:30 in right deltoid. Pt tolerated dose #1 in left deltoid. She developed mild arm " weakness" and soreness that lasted several days. She completed a VAERS report after her first dose. She began to feel " itchy all over" at 15:00. She noticed hives under her bilateral breasts. She felt " flushed" and her scalp and face felt itchy as well. No SOB or CP. NO wheezing. She has a hx of allergies to KEFLEX/PCN.
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| 59 | 2021-01-12 | itchy skin, tingling |
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving he...
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Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine. I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
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| 59 | 2021-01-12 | rash, injection site redness |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-13 | injection site pain, injection site warmth, injection site redness |
Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s an...
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Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s and chills 12 hours after injection lasting for 48 hours after. Took 800mg ibuprofen every 6 hours through 48 hours post injection with relief of myalgia?s and chills.
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| 59 | 2021-01-13 | injection site pain | Injection site pain/soreness, body ache. |
| 59 | 2021-01-13 | rash macular, itchy skin | Multiple red, itchy spots on hands and feet |
| 59 | 2021-01-13 | rash, skin spots | rash, petechia all over body, spread and got redder and redder |
| 59 | 2021-01-14 | vaccination site pain |
4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This ...
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4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-14 | injection site hardening, injection site redness, injection site warmth |
Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half doll...
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Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half dollar size red area which is hot to the touch with hardness or a knot at injection site. tHIS IS STILL PRESENT.
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| 59 | 2021-01-14 | skin burning sensation, itchy skin |
Five minutes after receiving injection patient experienced shortness of breath, itching and burning ...
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Five minutes after receiving injection patient experienced shortness of breath, itching and burning in left arm and hand, right arm. She reported taking 2 puffs of her Proair inhaler. She worried she would pass out as she was walking. She reported her condition to NP who did an assessment. At 9:40AM the patients vitals were BP: 147/104, HR=109, O2=98%, She was advised to lie down and was placed under observation for 15 minutes. Vitals were taken again at 9:55AM - BP=142/92, HR=103, O2=95%. The patient moved to the Travel, Immunization, and Allergy Clinic for further observation. Dr. examined the patient. He Heart rate was 116. The patient drank some water and juice and took an antihistamine (Claritin). She didn't want Benadryl as she didn't like the way it made her sleepy. After resting for 40 minutes, she stated that she felt better. Dr. checked on her again and said that she could go back to work if she felt OK and to be monitered by RN for the next hour. She rested and was checked at 10:30, 11:00, 11:30 AND 12:15 and reported feeling better.
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| 59 | 2021-01-14 | injection site bruising |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-14 | injection site pain |
Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior...
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Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior head and neck ache, and chills.
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| 59 | 2021-01-14 | vaccination site pain |
muscle soreness at greater injection site; This is a spontaneous report from a contactable other hea...
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muscle soreness at greater injection site; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number=EJ1685), intramuscular in left arm on 20Dec2020 16:00 at a single dose for Covid-19 immunization. Medical history included diabetes and hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has no allergies to medications, food or other products. The patient's concomitant medications included prescribed medication (unspecified). The patient experienced muscle soreness at greater injection site on 21Dec2020 at 06:00 AM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
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| 59 | 2021-01-14 | injection site pain |
soreness at injection site and sharp headache pain over my right eye that radiated to the back of my...
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soreness at injection site and sharp headache pain over my right eye that radiated to the back of my head, both started the night of the injection and through the next day
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| 59 | 2021-01-15 | injection site pain |
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ...
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Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
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| 59 | 2021-01-16 | itchy skin, tingling, hives |
Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and n...
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Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and needles" 20minutes after vaccine admin and then began itching. Presents to observation unit with red rash, 3-4 hives across upper and mid-back. Endorses itching on scalp as well as trunk. No rash noted on hands, arms, or face. Benadryl given after pt consulted with Dr. mild relief of symptoms. MDs spoke extensively with patient. She was ok to go home after her spouse arrived to drive her.
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| 59 | 2021-01-16 | itchy skin, tingling |
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s...
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Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
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| 59 | 2021-01-16 | tingling, hives, rash, itchy skin, redness |
left arm became red with rash that was raised like small pimples, I felt like something was prickin...
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left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
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| 59 | 2021-01-19 | redness, itchy skin |
0825 - complained of itchy right forearm, one 0.5 cm flat red area noted, has history of allergies (...
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0825 - complained of itchy right forearm, one 0.5 cm flat red area noted, has history of allergies ( stinging insects, crab). Given 25 mg benadryl po. 0855 - no further symptoms, area on right arm unchanged, no other itching, no respiratory symptoms. Not working today - MD in practice. Feels well enough to leave. Will follow up with her allergist.
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| 59 | 2021-01-19 | redness, hives, rash macular, itchy skin, tingling, injection site pain |
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut...
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Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
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| 59 | 2021-01-21 | injection site pain | Mild myalgia, malaise, soreness of injected arm |
| 59 | 2021-01-21 | tingling, shingles |
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting...
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Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
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| 59 | 2021-01-21 | itchy skin, rash |
Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) m...
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Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) middle and (3)ring finger a couple days afterward. Started to go away. Received second dose of COVID-19 on 1/11/2021. Rash continued to worsen. Noticed red rash on neck starting around 1/17/2021. Describes as "just a few red bumps and really itchy". "It felt like poison ivy itching". 1/20/2021, rash appeared to look like hives, swelling, and itchiness intensified. 1/22/2021, swelling subsided some, continues with rash and itchiness.
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| 59 | 2021-01-24 | tingling |
On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right ...
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On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right arm, all the way down to my finger tips. it lasted for 10-20 minutes then slowly improved. This also happened after the first shot but I didn't think much about it because it only lasted for 3-5 minutes was mild and it was mostly just tingling.
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| 59 | 2021-01-24 | injection site pain | PAIN INJECTION SITE, HEADACHE, CHILLS,PAIN ON JOINTS, TIRED,FEVER BODY PAIN. SINTOMES FOR 3 DAYS. |
| 59 | 2021-01-24 | injection site swelling |
Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hell...
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Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hello, I received my first Pfizer COVID vaccine on Friday Jan 22 at a health care program. On Friday I felt no arm discomfort, but had a stomach ache all day. Saturday I was very tired and in the evening I noticed my left shot shoulder/arm pit area, bra line area was swollen and uncomfortable. Woke up in the night feeling like my left arm pit, and breast area was more swollen and if I had to paint it I would describe it as tiny bubbles all enlarged underneath my skin. Guessing it is my lymph nodes? This unusual feeling has since spread to the left side of my neck inside my throat and out. It is not painful, I have taken a warm shower, only wearing loose, comfy clothing and am sitting with a warm bean pillow on my neck. I just wanted to report how I am feeling if others are having similar reactions."
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| 59 | 2021-01-24 | hives |
hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue th...
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hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue thickness. Rapid response team notified. Epinephrine given and patient transported to ER
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| 59 | 2021-01-24 | injection site bruising, injection site pain |
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ...
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soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
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| 59 | 2021-01-25 | shingles |
Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored pr...
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Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Patient received SHINGRIX in 2020 and shingles vaccine in 2011 (also reported in 2020), flu shot in 2020 (Sep2020 or Oct2020); all vaccines received for immunisation. On 12Jan2021, the patient developed Shingles; the patient did not visit the emergency room. The patient was due for the second dose of suspect vaccine on the 19Jan2021. The patient did not recover from the event.
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| 59 | 2021-01-26 | hives, itchy skin |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | injection site inflammation |
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai...
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Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
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| 59 | 2021-01-26 | tingling |
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i...
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My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
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| 59 | 2021-01-26 | tingling |
NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD T...
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NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD TIGHTNESS IN THE BACK OF THE THROAT
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| 59 | 2021-01-26 | tingling |
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al...
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Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
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| 59 | 2021-01-26 | itchy skin, hives |
Started itching all over her body mainly neck and back underneath hairline around 8:00 PM, when she ...
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Started itching all over her body mainly neck and back underneath hairline around 8:00 PM, when she got home still itching but worse. Got up to look in the bathroom and had hives on side of neck, back of neck, down her back, right leg and hands were itchy, feet itchy but no hives. Right now her hands are itchy and the bottom of her hands are itchy. Took Benadryl and the other symptoms have resolved. Fell asleep after the Benadryl. No markings at this time, just the palms of her hands and feet itching.
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| 59 | 2021-01-26 | redness, injection site pain, injection site nodule |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-26 | vaccination site pain |
chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable o...
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chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.
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| 59 | 2021-02-02 | itchy skin |
Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is...
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Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included "sensimist", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-02-06 | rash |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
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| 59 | 2021-02-07 | tingling |
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo...
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Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
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| 59 | 2021-02-14 | rash |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
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| 59 | 2021-02-21 | injection site redness |
I went to get my second Covid - 19 Pfizer- BioNTech vaccine Saturday night 2/20/21 at 7:30 pm. The...
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I went to get my second Covid - 19 Pfizer- BioNTech vaccine Saturday night 2/20/21 at 7:30 pm. The nurse wiped my right arm with alcohol, threw out the wrapper, and then got the vaccine. I was in the passenger side so she needed to open the door. I felt the needle go in my arm, but a line of liquid went down my arm to my wrist as she gave the shot. I asked if that was supposed to happen and the nurse said "it was the alcohol". I was concerned since the alcohol had already been wiped on my arm and I would have felt that when she wiped it. I am concerned because the liquid came out when the shot was given. I am now worried that I didn't get the vaccine. My arm is red where the injection was but I have no side effects. I need to report this since it did not seem right and I don't know if the vaccine was given to me fully.
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| 59 | 2021-02-21 | injection site pain |
Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection s...
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Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection site was expected!)
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| 59 | 2021-02-22 | injection site pain |
02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolv...
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02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
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| 59 | 2021-02-23 | hives, vaccination site pain |
Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head thr...
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Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.
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| 59 | 2021-02-23 | redness |
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe...
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small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
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| 59 | 2021-02-24 | rash |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-24 | vaccination site pain |
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen...
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Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
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| 59 | 2021-03-02 | rash papular, itchy rash |
diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis...
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diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; Mild scratchy throat; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249), via an unspecified route of administration on 29Jan2021 13:15 at single dose (right arm) for COVID-19 immunization. Medical history included occasional gastric reflux and allergies. The patient was not pregnant. Patient had unspecified concomitant medications which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 20:00, the patient developed a diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also, pruritis on back abdomen arms and legs and mild scratchy throat. The patient noticed these symptoms several hours after injection and was worse on day 2. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
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| 59 | 2021-03-03 | redness |
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ...
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her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
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| 59 | 2021-03-03 | tingling |
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t...
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mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-09 | vaccination site pain |
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ...
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having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
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| 59 | 2021-03-10 | redness |
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ...
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I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
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| 59 | 2021-03-14 | itchy skin |
Itching all over body is still occurring and it has been 3 weeks; This is a spontaneous report from ...
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Itching all over body is still occurring and it has been 3 weeks; This is a spontaneous report from a consumer or other non-health care professional. A 59-years-old female patient started to receive BNT162b2 (BNT162B2), via an unspecified route of administration from 14Jan2021 15:45 to 14Jan2021 15:45 at single dose for covid-19 immunisation. Medical history included asthma, crohn's disease (Crohn's disease has been in remission 13 years), food allergy and known allergies (dairy, seasonal allergy, dust allergy, allergy to animal) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine (FLUOXETINE), fluticasone propionate, salmeterol xinafoate (ADVAIR), progesterone (PROGESTERONE) and estradiol (ESTRADIOL). On 14Jan2021, the patient experienced itching all over body is still occurring and it has been 3 weeks. The action taken in response to the event for BNT162b2 was not applicable. Therapeutic measures were taken as a result of itching all over body is still occurring and it has been 3 weeks (pruritus). The outcome of event was not recovered.
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| 59 | 2021-03-14 | itchy skin |
left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthca...
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left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581 and expiry date unknown), via an unspecified route of administration in the left arm on 10Feb2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medications included vitamin D NOS and vitamin C [ascorbic acid]. Patient experienced left eyelid swollen, itchy, and a little weepy on 10Feb2021 18:30. Patient was recovering from the events. No treatment was received for the adverse events. This case was reported as non-serious.
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| 59 | 2021-03-15 | vaccination site redness, vaccination site pain, vaccination site swelling |
arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when s...
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arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 59 years of age), via an unspecified route of administration in the left arm on 25Feb2021 14:15 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included chronic blood clot in left leg from an unknown date and unknown if ongoing and environmental allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She was not pregnant. The patient had not had covid prior vaccination and she had not been tested post vaccination. It was reported that during the night of 25Feb2021 at 11:00 PM, the patient's arm was very sore when she got up it was swollen and red and hurt terribly. So she went to the ER because she had a chronic blood clot in her left leg; there was no clot in her arm but it was still swollen, red and it hurts. She added that she have very bad environment allergies and queried if she should get the second shot. No treatment received for the events. The outcome of the events was unknown; the events resulted to emergency room visit. Information on the lot/batch number has been requested.
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| 59 | 2021-03-16 | tingling |
I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting t...
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I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this.
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| 59 | 2021-03-18 | vaccination site pain |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-18 | injection site pain |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-22 | redness |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-03-30 | rash |
Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood d...
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Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
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